These Highlights Do Not Include All The Information Needed To Use Bimzelx Safely And Effectively. See Full Prescribing Information For Bimzelx.

• Injection (1 mL): 160 mg/mL clear to slightly opalescent, and colorless to pale brownish-yellow solution in a single-dose prefilled syringe or single-dose prefilled autoinjector.
• Injection (2 mL): 320 mg/2 mL (160 mg/mL) clear to slightly opalescent, and colorless to pale brownish-yellow solution in a single-dose prefilled syringe or single-dose prefilled autoinjector.

Storage and Handling

Store cartons with BIMZELX refrigerated between 2°C to 8°C (36°F to 46°F). Keep the product in the original carton to protect it from light until the time of use. Do not freeze. Do not shake. Do not use beyond expiration date. BIMZELX does not contain a preservative; discard any unused portion.

When necessary, BIMZELX prefilled syringes or autoinjectors may be stored at room temperature up to 25°C (77°F) in the original carton for a single period of up to 30 days. Once BIMZELX prefilled syringes or autoinjectors have been stored at room temperature, do not place back in refrigerator. Write the date removed from the refrigerator in the space provided on the carton and discard if not used within a 30-day period.

Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa.

BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use.

Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1.

Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1.

BIMZELX may increase the risk of infections, including serious infections.

Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated.

In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and discontinue BIMZELX until the infection resolves.

If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regularly scheduled interval.

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients treated with BIMZELX for signs and symptoms of active TB during and after treatment.

Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX. Limited data are available regarding coadministration of BIMZELX with non-live vaccines [see Clinical Pharmacology (12.2)] .

The safety and effectiveness of BIMZELX in pediatric patients have not been established.

Of the 1,789 subjects with plaque psoriasis that were exposed to BIMZELX, a total of 153 subjects were 65 years of age or older, and 18 subjects were 75 years of age or older. Although no differences in safety or effectiveness were observed between subjects 65 years of age or older and younger adult subjects, clinical trials in PSO did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects .

Of the 1,197 subjects with PsA that were exposed to BIMZELX, a total of 148 were 65 years of age and older. Although no differences in safety or effectiveness were observed between subjects 65 years of age or older and younger adult subjects, clinical trials in PsA did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects .

Of the 244 subjects with nr-axSpA that were exposed to BIMZELX, a total of 6 were 65 years of age and older. Although no differences in safety or effectiveness were observed between subjects 65 years of age or older and younger adult subjects, the clinical trial in nr-axSpA did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects .

Of the 330 subjects with AS that were exposed to BIMZELX, a total of 11 were 65 years of age and older. Although no differences in safety or effectiveness were observed between subjects 65 years of age or older and younger adult subjects, the clinical trial in AS did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects .

Of the 995 subjects with hidradenitis suppurativa that were exposed to BIMZELX, a total of 18 were 65 years of age and older. Although no differences in safety or effectiveness were observed between subjects 65 years of age or older and younger adult subjects, clinical trials in HS did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects .

The observed incidence of anti-drug antibodies (ADA) is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of ADA in the studies described below with the incidence of ADA in other studies, including those of BIMZELX or of other bimekizumab products.

Across the pivotal trials in all indications, there was no identified clinically significant effect of anti-bimekizumab-bkzx antibodies, including neutralizing anti-drug antibodies, on safety or effectiveness of BIMZELX.

None.

The following adverse reactions have been observed with BIMZELX and are discussed in greater detail in other sections of the labeling:

• Suicidal Ideation and Behavior [see Warnings and Precautions (5.1)]
• Infections [see Warnings and Precautions (5.2)]
• Liver Biochemical Abnormalities [see Warnings and Precautions (5.4)]
• Inflammatory Bowel Disease [see Warnings and Precautions (5.5)]

BIMZELX is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

This Instructions for Use contains information on how to inject BIMZELX.

Read this Instructions for Use before using the BIMZELX autoinjector and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

These instructions are for 1 injection only. You may need more than 1 injection at a time depending on your prescribed dose of BIMZELX. Each BIMZELX autoinjector is for one-time (single-dose) use only.

Important Information you Need to Know Before Injecting BIMZELX:

• Your healthcare provider should show you or a caregiver how to prepare and inject BIMZELX using the autoinjector for the first time. Do not inject yourself or someone else until you have been shown how to inject BIMZELX the right way. Call your healthcare provider if you have any questions.
• These instructions are for 1 injection only.
• The BIMZELX autoinjector has a needle safety feature that will be activated to cover the needle after the injection is finished. The needle safety feature will help to prevent needle stick injuries to anyone who handles the autoinjector after injection.
• Do notshare or reuse your BIMZELX autoinjector. You may give or get an infection.
• Do notremove the needle cap until just before you give the injection.
• If you have vision or hearing problems, do notuse the BIMZELX autoinjector without help from a caregiver.

How should I store BIMZELX autoinjector?

• Store the BIMZELX autoinjector in the refrigerator between 36°F to 46°F (2°C to 8°C).
• BIMZELX autoinjectors may be stored at room temperature up to 77°F (25°C) in the original carton for up to 30 days. Do notplace BIMZELX autoinjectors back in the refrigerator after they have been stored at room temperature.
• Write the date removed from the refrigerator in the space provided on the carton and throw away if it has been kept at room temperature and not used within 30 days.
• Keep BIMZELX in the original carton until ready for use to protect from light.
• Do not freeze BIMZELX.
• Do not shake BIMZELX.
• Do not use the BIMZELX autoinjector past the expiration date printed on the carton.

Keep BIMZELX autoinjectors and all medicines out of the reach of children.

BIMZELX autoinjector parts (see Figure A):

Supplies Needed for each BIMZELX injection

• 1 BIMZELX autoinjector. You may need 2 BIMZELX autoinjectors to give the prescribed dose.

Not provided in the BIMZELX autoinjector carton:

• 1 alcohol swab
• 1 clean cotton ball
• 1 sharps disposal container. See, " Step 12: Dispose of (throw away) the used BIMZELX autoinjector " at the end of this Instructions for Use.

Setting up for your BIMZELX injection.

Step 1: Take the BIMZELX autoinjector carton out of the refrigerator. Do notuse the BIMZELX autoinjector(s) if the carton seal is broken. Throw it away and get a new one.

• Keep the BIMZELX autoinjector in its original carton for 30 to 45 minutesto warm to room temperature. This will help to reduce discomfort when injecting.
  • Do notmicrowave the autoinjector, run hot water over it, or leave it in direct sunlight.
  • Do notshake the autoinjector.
  • Do nottake the cap off the autoinjector until you are ready to inject.

Step 2: Find a clean, flat, and well-lit work surface, like a table.

Step 3:Gather the supplies needed for your injection.

Step 4:Wash your hands well with soap and water and dry with a clean towel.

Step 5:Inspect the BIMZELX autoinjector (see Figure B):

• Remove the BIMZELX autoinjector from the carton.
• Make sure the name BIMZELX appears on the label.
  • Check the expiration date printed on the label.
  • Check the medicine through the Viewing Window. The medicine inside should be clear to slightly pearly, and colorless to pale brownish-yellow. You may see air bubble(s) in the liquid. This is normal.
• Do not use the BIMZELX autoinjector,throw it away and get a new one if:
  • The expiration date printed on the label has passed.
  • The medicine is cloudy, discolored, or has particles.
  • It looks damaged or has been dropped.

Choose and prepare your injection site.

Step 6: Choose and clean your injection site.

• The sites you may choose for your injection are:
  • your stomach area (abdomen) or your thigh (see Figure C ).
  • the back of your arm ( see Figure D ). BIMZELX may be injected into the back of your arm by a healthcare provider or caregiver only.

• Do notinject into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis , or within 2 inches of the belly button (navel).
• Choose a new injection site on the body each time you use BIMZELX. Do notuse the same injection site 2 times in a row.

Step 7: Prepare your skin

• Clean the injection site with an alcohol swab. Let the area dry completely. Do nottouch the cleaned area again before injecting.

Injecting BIMZELX.

Step 8: Remove the BIMZELX autoinjector cap.

• Hold the BIMZELX autoinjector firmly with one hand around the handle. Pull the cap straight off (away from) the autoinjector with the other hand ( see Figure E ). Although you cannot see the needle tip, it is now uncovered.
  • Putthe cap into an FDA-cleared sharps disposal container right away. You will not need it again.
  • Do nottouch the needle guard or put the cap back on as it could activate the autoinjector and you can stick yourself.

Step 9:Hold the BIMZELX autoinjector at a 90-degree angle to the cleaned injection site (see Figure F).

Step 10:Place the BIMZELX autoinjector flat against your skin, then firmly press the BIMZELX autoinjector down against your skin. You will hear a "click" sound. Your injection begins when the 1 ^st"click" is heard (see Figure G) .

• Do notlift the autoinjector away from the skin.

Keep holding the BIMZELX autoinjector in place and pressed firmly against your skin. It will take about 15 seconds to receive your full dose.

• You will hear a 2 ^nd"click" in about 15 seconds after you hear the first click.
• The second click tells you that all the medicine has been injected and your BIMZELX injection is finished. You should see the yellow color indicator filling the viewing window (see Figure H) .
• Important:When you remove the autoinjector, if the viewing window has not turned yellow this means you may not have received a full dose. Call your healthcare provider right away.

Step 11:Remove the BIMZELX autoinjector by carefully pulling the BIMZELX autoinjector straight up from your skin. The needle guard will automatically cover the needle. Do nottry to touch the needle.

• Press a clean cotton ball over the injection site for a few seconds. Do notrub the injection site. You may see slight bleeding or a drop of liquid. This is normal. You may cover the injection site with a small adhesive bandage, if needed.

Step 12: Dispose of (throw away) the used BIMZELX autoinjector (see Figure I).

• Put the used BIMZELX autoinjector in an FDA-cleared sharps disposal container right away after use. Do notthrow away (dispose of) the BIMZELX autoinjector in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
• Do notrecycle your used sharps disposal container.
  
  

Step 13: Repeat steps 1 through 12 with a new BIMZELX autoinjector if you need to use 2 autoinjectors to give the prescribed dose.

• Make sure you select a new injection site on the body each time you use BIMZELX. Do notuse the same site that you used for your first injection.

You can sign up to receive sharps containers for BIMZELX autoinjector disposal at no additional cost by going to www.BIMZELX.comor call 1-844-599-2273.

Manufactured by:

UCB, Inc. 1950 Lake Park Drive Smyrna, GA 30080

US License No. 1736

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Issued: 9/2024

Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin, and lesional skin in HS. Bimekizumab-bkzx exposure-response relationships to serum biomarkers, including IL-17A and IL-17F, and the time course of such pharmacodynamic responses are unknown.

Bimekizumab-bkzx pharmacokinetics are comparable in adult patients with moderate to severe plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis.

The median peak plasma concentration of bimekizumab-bkzx was 25 (range: 12-50) μg/mL and was reached in 3-4 days. Bimekizumab-bkzx exhibited dose-proportional pharmacokinetics in patients with plaque psoriasis over a dose range of 64 mg to 480 mg (0.2 to 1.5 times the approved recommended dosage) following subcutaneous administration.

The median steady-state trough concentration of bimekizumab-bkzx was approximately 40% lower in HS subjects than that of PSO subjects.

Three multicenter, randomized, double-blind trials [Trial Ps-1 (NCT03370133), Trial Ps-2 (NCT03410992), and Trial Ps-3 (NCT03412747)] enrolled a total of 1,480 subjects 18 years of age and older with moderate to severe plaque psoriasis who had a body surface area (BSA) involvement of ≥10%, an Investigator's Global Assessment (IGA) score of ≥3 ("moderate") in the overall assessment of psoriasis on a severity scale of 0 to 4, and a Psoriasis Area and Severity Index (PASI) score ≥12.

In Trial Ps-1, 567 subjects were randomized to receive either BIMZELX 320 mg by subcutaneous injection every 4 weeks, ustekinumab (for subjects weighing ≤100kg, 45 mg initially and 4 weeks later, then every 12 weeks; for subjects weighing >100kg, 90 mg initially and 4 weeks later, then every 12 weeks), or placebo through Week 52. At Week 16, subjects originally randomized to placebo received BIMZELX 320 mg every 4 weeks through Week 52.

In Trial Ps-2, 435 subjects were randomized to either BIMZELX 320 mg by subcutaneous injection every 4 weeks or placebo. At Week 16, subjects who achieved a PASI 90 response continued into a 40-week randomized withdrawal period. Subjects originally randomized to BIMZELX 320 mg every 4 weeks were re-randomized to either BIMZELX 320 mg every 4 weeks or BIMZELX 320 mg every 8 weeks or placebo. Subjects originally randomized to placebo continued to receive placebo if they were PASI 90 responders. Subjects who did not achieve a PASI 90 response at week 16 entered an open-label escape arm and received BIMZELX 320 mg every 4 weeks for 12 weeks. Subjects who relapsed, defined as having a less than PASI 75 response compared to baseline, during the randomized withdrawal period also entered the 12-week escape arm.

In Trial Ps-3, 478 subjects were randomized to receive either BIMZELX 320 mg by subcutaneous injection every 4 weeks through week 56, BIMZELX 320 mg every 4 weeks through week 16 followed by BIMZELX every 8 weeks through week 56, or adalimumab (80 mg as an initial dose followed by 40 mg every other week starting 1 week after initial dose through Week 24) followed by BIMZELX 320 mg every 4 weeks through Week 56.

In Trial Ps-1, Trial Ps-2, and Trial Ps-3, 71% of the subjects were male and 84% of the subjects were White, with a mean age of 45 years and a mean weight of 89 kg. At baseline, subjects had a median baseline PASI score of 18, median baseline for BSA of 20%, and baseline IGA score of 4 ("severe") in 33% of subjects. A total of 93% subjects had psoriasis of the scalp (Scalp IGA score of ≥1) and a total of 26% of subjects had a history of psoriatic arthritis. Additionally, 38% had received prior biologic therapy.

BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of:

• Moderate to severe plaque psoriasis (PSO)in adults who are candidates for systemic therapy or phototherapy. ( 1.1)
• Adults with active psoriatic arthritis (PsA). ( 1.2)
• Adults with active non-radiographic axial spondyloarthritis( nr-axSpA) with objective signs of inflammation. ( 1.3)
• Adults with active ankylosing spondylitis( AS). ( 1.4)
• Adults with moderate to severe hidradenitis suppurativa (HS). ( 1.5)

BIMZELX is indicated for the treatment of adults with active psoriatic arthritis.

Bimekizumab-bkzx is a humanized immunoglobulin IgG1/ κ monoclonal antibody with two identical antigen binding regions that selectively bind to human interleukin 17A (IL-17A), interleukin 17F (IL-17F), and interleukin 17-AF cytokines, and inhibits their interaction with the IL-17 receptor complex. IL-17A and IL-17F are naturally occurring cytokines that are involved in normal inflammatory and immune responses. Bimekizumab-bkzx inhibits the release of proinflammatory cytokines and chemokines.

The safety and efficacy of BIMZELX were assessed in 1,112 subjects in two multicenter, randomized, double-blind, placebo-controlled studies [Trial PsA-1 (NCT 03895203) and Trial PsA-2 (NCT 03896581)] in subjects 18 years and older with active psoriatic arthritis (PsA).

Subjects in these studies had a diagnosis of PsA of at least 6 months based on Classification Criteria for Psoriatic Arthritis (CASPAR), a median duration of 4.6 years at baseline, and active disease with ≥3 tender joint count and ≥3 swollen joint count. Subjects with each subtype of PsA were enrolled in these studies, including polyarticular symmetric arthritis (63.5%), oligoarticular asymmetric arthritis (25.9%), distal interphalangeal joint predominant (4.4%), spondylitis predominant (4.2%), and arthritis mutilans (1.5%). At baseline, 56% of subjects had ≥3% Body Surface Area (BSA) with active plaque psoriasis. At baseline across both studies, 32% and 12% of subjects had enthesitis and dactylitis, respectively, 58% of subjects had psoriatic nail disease, and 53% of subjects were receiving concomitant methotrexate.

The PsA-1 study evaluated 852 biologic-naïve subjects, who were treated with either BIMZELX 160 mg every 4 weeks up to Week 52, adalimumab 40 mg every 2 weeks up to Week 52 (active reference arm), or placebo. Subjects receiving placebo were switched to BIMZELX every 4 weeks at Week 16 to Week 52. In this study, 78% of subjects had received prior treatment with ≥ 1 conventional DMARDs (cDMARDs), and 22 % of subjects had no prior treatment with cDMARDs. At baseline, 58% of subjects were receiving concomitant methotrexate (MTX), 11% were receiving concomitant cDMARDs other than MTX, and 31% were receiving no cDMARDs. The PsA-2 study evaluated 400 anti-TNFα experienced subjects (inadequate response or intolerance to treatment), who were treated with BIMZELX 160 mg every 4 weeks or placebo up to Week 16. In this study, 43% of subjects were receiving concomitant MTX, 8% were receiving concomitant cDMARDs other than MTX, and 50% were receiving no cDMARDs.

For both studies, the primary endpoint was the proportion of subjects who achieved an America College of Rheumatology (ACR) 50 response at Week 16.

BIMZELX is indicated for the treatment of adults with active ankylosing spondylitis.

• Suicidal Ideation and Behavior (SI/B): May increase risk of SI/B. Advise patients, their caregivers, and families to monitor for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, instruct patients to promptly seek medical attention or call the National Suicide and Crisis Lifeline at 988. Carefully weigh risks and benefits of treatment with BIMZELX in patients with a history of severe depression and/or suicidal ideation or behavior. ( 5.1)
• Infections: May increase risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If such an infection develops, do not administer BIMZELX until the infection resolves. ( 5.2)
• Tuberculosis (TB): Avoid use in patients with active TB. Initiate treatment of latent TB prior to BIMZELX treatment. ( 5.3)
• Liver Biochemical Abnormalities: Elevated serum transaminases were reported in clinical trials. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline and according to routine patient management. Permanently discontinue use of BIMZELX in patients with causally - associated combined elevations of transaminases and bilirubin. ( 5.4)
• Inflammatory Bowel Disease (IBD): Cases of IBD were reported in clinical trials with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. Monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs. ( 5.5)
• Immunizations: Avoid the use of live vaccines in patients treated with BIMZELX. ( 5.6)

The efficacy and safety were assessed in 332 patients in one randomized, double-blind, placebo-controlled study [Trial AS-1 (NCT03928743)] in adult subjects 18 years of age and older with active ankylosing spondylitis. Subjects had to have documented radiologic evidence (x-ray) fulfilling the Modified New York criteria for AS. Subjects had active disease as defined by BASDAI ≥4 and spinal pain ≥4 on a 0 to 10 numeric rating scale (NRS) (from BASDAI Item 2). Subjects also had a history of inadequate response to 2 different non-steroidal anti-inflammatory drugs (NSAIDs), or intolerance or contraindication to NSAIDs. Approximately 20% of subjects were on concomitant cDMARDs. Overall, 16% of subjects had received previous treatment (failed or were intolerant to) with anti-TNF alpha agents.

Subjects were randomized 2:1 to receive BIMZELX 160 mg or placebo every 4 weeks up to the completion of Week 16 assessments. Starting at Week 16, all subjects received BIMZELX every 4 weeks up to Week 52. The primary endpoint was at least 40% improvement in Assessment of Spondyloarthritis International Society (ASAS 40) at Week 16.

• Prior to treatment: ( 2.1)
  
  
  • Evaluate patients for tuberculosis infection.
  • Test liver enzymes, alkaline phosphatase, and bilirubin.
  • Complete all age-appropriate vaccinations as recommended by current immunization guidelines.
• Plaque Psoriasis
  • Administer 320 mg by subcutaneous injection at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing 120 kg or more, consider a dose of 320 mg every 4 weeks after Week 16. ( 2.2)
• Psoriatic Arthritis
  • Administer 160 mg by subcutaneous injection every 4 weeks. ( 2.3)
  • For patients with coexisting moderate to severe plaque psoriasis, use the dosage and administration for plaque psoriasis. ( 2.2)
• Non-Radiographic Axial Spondyloarthritis
  • Administer 160 mg by subcutaneous injection every 4 weeks. ( 2.4)
• Ankylosing Spondylitis
  • Administer 160 mg by subcutaneous injection every 4 weeks. ( 2.5)
• Hidradenitis Suppurativa
  • Administer 320 mg by subcutaneous injection at Week 0, 2, 4, 6, 8, 10, 12, 14 and 16, then every 4 weeks thereafter. ( 2.6)
• See full prescribing information for recommendations regarding missed doses, preparation and administration instructions. ( 2.7, 2.8, 2.9)

BIMZELX is indicated for the treatment of adults with moderate to severe hidradenitis suppurativa.

• Before injecting, remove the carton with BIMZELX from the refrigerator and allow BIMZELX to reach room temperature (30 to 45 minutes) without removing the prefilled syringes or autoinjectors from the carton to protect from light.
• Inspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit. BIMZELX injection is clear to slightly opalescent, and colorless to pale brownish- yellow. Do not use if the solution contains visible particles, is discolored or cloudy.

• Injection: 160 mg/mL in a single-dose prefilled syringe or single-dose prefilled autoinjector. ( 3)
• Injection: 320 mg/2 mL (160 mg/mL) in a single-dose prefilled syringe or single-dose prefilled autoinjector. ( 3)

The following adverse reactions have been reported during post-approval use of BIMZELX. Because they are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Infections:conjunctivitis, esophageal candidiasis

The safety and efficacy of BIMZELX were assessed in two Phase 3 multicenter, randomized, double-blind, placebo-controlled trials [Trial HS-1 (NCT04242446) and Trial HS-2 (NCT04242498)] in 1,014 adult subjects with moderate to severe HS of at least 6 months with Hurley Stage II or Hurley Stage III disease, and with ≥5 inflammatory lesions [i.e., number of abscesses plus number of inflammatory nodules (AN count)], and a history of inadequate response to a course of systemic antibiotics for the treatment of HS.

Subjects received BIMZELX 320 mg every 2 weeks (Q2W) for 48 weeks, or BIMZELX 320 mg every 4 weeks (Q4W) up to Week 48, or BIMZELX 320 mg Q2W to Week 16, followed by 320 mg Q4W up to Week 48, or placebo. At Week 16, subjects receiving placebo were switched to BIMZELX 320 mg Q2W to Week 48. Concomitant oral doxycycline, minocycline, or an equivalent systemic tetracycline for HS was allowed if the subject was on a stable dose regimen for 28 days prior to baseline.

In these trials, at baseline the mean age of all subjects was 37 years, 57% of subjects were female, 80% were White, 11% were Black or African American, and 4% were Asian; for ethnicity, 7% identified as Hispanic or Latino. Of the subjects enrolled in trials conducted in the United States, 33% were Black or African American. The mean BMI was 33, and 46% were current smokers. Subjects had a median disease duration of 5 years. Overall, 9% of subjects were receiving concomitant antibiotic therapy for HS, and 19% of subjects had received previous treatment with biologics. The proportion of Hurley Stage II and Stage III subjects were 56% and 44%, respectively. Additionally, the mean number of draining tunnels was 3.6 and mean AN count was 16.3.

The primary efficacy endpoint in both trials was the Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16, defined by at least a 50% reduction in total abscess and inflammatory nodule count with no increase in abscess or draining tunnel count relative to baseline. Secondary endpoints included the proportion of subjects who achieved HiSCR75 and HS-specific skin pain response as assessed by a 0 to 10 numeric rating scale (NRS).

Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX [see Adverse Reactions (6.1)]. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

• BIMZELX is intended for use under the guidance and supervision of a healthcare professional. Patients may self-inject after training in subcutaneous injection technique. Provide proper training to patients and/or caregivers on the subcutaneous injection technique of BIMZELX according to the "Instructions for Use" [see Instructions for Use].
• If two separate 160 mg injections are used to achieve the recommended dose, administer each injection subcutaneously at a different anatomic location (such as thighs, abdomen or back of upper arm). Discard the syringes or autoinjectors after use. Do not reuse.
• Do not inject BIMZELX within 2 inches (5 cm) of the navel or into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis. Administration of BIMZELX in the upper, outer arm may only be performed by a healthcare professional or caregiver. Rotate the injection site with each injection.

Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

An increased incidence of new onset or worsening suicidal ideation and behavior was observed in subjects treated with BIMZELX. A causal association between treatment with BIMZELX and increased risk of suicidal ideation and behavior has not been definitively established.

Suicidal ideation and behavior were prospectively monitored using the Columbia Suicide Severity Rating Scale (C-SSRS) in clinical trials. The C-SSRS is an interview-based instrument used to monitor for the presence and severity of suicidal ideation (ranging from "none" to "active suicidal ideation with specific plan and intent") and behaviors (rating the injury and potential lethality of self-injury, if present).

Treatment with BIMZELX was associated with increased incidence of liver enzyme elevations compared to treatment with placebo in randomized clinical trials. Liver serum transaminase elevations > 3 times the upper limit of normal were reported in subjects treated with BIMZELX [see Adverse Reactions (6.1)] . Elevated liver serum transaminases resolved after discontinuation of BIMZELX.

Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with BIMZELX and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded. Permanently discontinue BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Patients with acute liver disease or cirrhosis may be at increased risk for severe hepatic injury; avoid use of BIMZELX in these patients.

The recommended dosage is 320 mg by subcutaneous injection at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter .For patients weighing 120 kg or more, consider a dosage of 320 mg every 4 weeks after Week 16 [see Clinical Pharmacology (12.3)] .

BIMZELX is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.

The efficacy and safety were assessed in 254 patients in one randomized, double-blind, placebo-controlled study [Trial nr-axSpA-1 (NCT03928704)] in adult subjects 18 years of age and older with active non-radiographic axial spondyloarthritis. Subjects had to have objective signs of inflammation with elevated C-reactive protein (CRP) level and/or evidence of sacroiliitis on Magnet Resonance Imaging (MRI). Subjects met ASAS classification criteria for axial spondyloarthritis and have active disease as defined by BASDAI greater than or equal to 4, spinal pain of greater than or equal to 4 (0-10 numeric rating scale (NRS)), and no definitive radiographic evidence of structural damage in the sacroiliac joints. At baseline, 73% of subjects had enthesitis. Subjects also had a history of inadequate response to 2 different non-steroidal anti-inflammatory drugs (NSAIDs), or intolerance or contraindication to NSAIDs. Approximately 24% of subjects were on concomitant cDMARDs. Overall, 11% of subjects had received previous treatment (failed or were intolerant to) with anti-TNF alpha agents.

Subjects were randomized to receive BIMZELX 160 mg or placebo every 4 weeks up to the completion of Week 16 assessments. Starting at Week 16, all subjects received BIMZELX every 4 weeks up to Week 52. The primary endpoint was at least 40% improvement in Assessment of Spondyloarthritis International Society (ASAS 40) at Week 16.

The recommended dosage is 160 mg by subcutaneous injection every 4 weeks.

For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosing regimen for adult patients with plaque psoriasis [see Dosage and Administration (2.2)] .

The recommended dosage is 160 mg by subcutaneous injection every 4 weeks.

NDC 50474-780-79

Rx ONLY

ATTENTION: Dispense enclosed

Medication Guide to each patient.

Bimzelx ^®

(bimekizumab-bkzx) Injection

160 mg/mL per syringe

FOR SUBCUTANEOUS USE ONLY

Two single-dose prefilled

syringes. Each syringe

delivers 160 mg in 1 mL

of bimekizumab-bkzx.

For a 320 mg dose, two 160 mg

prefilled syringes are required.

The recommended dosage is 320 mg by subcutaneous injection at Weeks 0, 2, 4, 6, 8, 10, 12, 14, and 16, then every 4 weeks thereafter.

NDC 50474-783-78

Rx ONLY

ATTENTION: Dispense enclosed

Medication Guide to each patient.

Bimzelx ^®

(bimekizumab-bkzx) Injection

320 mg/2 mL (160 mg/mL)

syringe

FOR SUBCUTANEOUS USE ONLY

One single-dose prefilled syringe.

Each syringe delivers 320 mg

in 2 mL of bimekizumab-bkzx.

NDC 50474-781-85

Rx ONLY

ATTENTION: Dispense enclosed

Medication Guide to each patient.

Bimzelx ^®

(bimekizumab-bkzx) Injection

160 mg/mL per autoinjector

FOR SUBCUTANEOUS USE ONLY

Two single-dose autoinjectors.

Each autoinjector delivers 160 mg

in 1 mL of bimekizumab-bkzx.

For a 320 mg dose, two 160 mg

autoinjectors are required.

Carcinogenicity and mutagenicity studies have not been conducted with bimekizumab-bkzx.

No effects on fertility parameters such as effects on reproductive organs, menstrual cycle length, or sperm analysis were observed in sexually mature cynomolgus monkeys that were subcutaneously administered 200 mg/kg/week bimekizumab-bkzx (150 times the MRHD, based on mg/kg comparison) for 26 weeks. The monkeys were not mated to evaluate fertility.

NDC 50474-782-84

Rx ONLY

ATTENTION: Dispense enclosed

Medication Guide to each patient.

Bimzelx ^®

(bimekizumab-bkzx) Injection

320 mg/2 mL autoinjector

FOR SUBCUTANEOUS USE ONLY

One single-dose autoinjector.

Each autoinjector delivers 320 mg

in 2 mL of bimekizumab-bkzx.

The recommended dosage is 160 mg by subcutaneous injection every 4 weeks.

• Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX [see Warnings and Precautions (5.3)] .
• Test liver enzymes, alkaline phosphatase and bilirubin prior to initiating treatment with BIMZELX [see Warnings and Precautions (5.4)] .
• Complete all age-appropriate vaccinations as recommended by current immunization guidelines [see Warning and Precautions (5.6)] .

• Injection (1 mL): 160 mg/mL clear to slightly opalescent, and colorless to pale brownish-yellow solution in a single-dose prefilled syringe or single-dose prefilled autoinjector.
• Injection (2 mL): 320 mg/2 mL (160 mg/mL) clear to slightly opalescent, and colorless to pale brownish-yellow solution in a single-dose prefilled syringe or single-dose prefilled autoinjector.

Storage and Handling

Store cartons with BIMZELX refrigerated between 2°C to 8°C (36°F to 46°F). Keep the product in the original carton to protect it from light until the time of use. Do not freeze. Do not shake. Do not use beyond expiration date. BIMZELX does not contain a preservative; discard any unused portion.

When necessary, BIMZELX prefilled syringes or autoinjectors may be stored at room temperature up to 25°C (77°F) in the original carton for a single period of up to 30 days. Once BIMZELX prefilled syringes or autoinjectors have been stored at room temperature, do not place back in refrigerator. Write the date removed from the refrigerator in the space provided on the carton and discard if not used within a 30-day period.

Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa.

BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use.

Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1.

Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1.

BIMZELX may increase the risk of infections, including serious infections.

Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated.

In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and discontinue BIMZELX until the infection resolves.

If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regularly scheduled interval.

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients treated with BIMZELX for signs and symptoms of active TB during and after treatment.

Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX. Limited data are available regarding coadministration of BIMZELX with non-live vaccines [see Clinical Pharmacology (12.2)] .

The safety and effectiveness of BIMZELX in pediatric patients have not been established.

Of the 1,789 subjects with plaque psoriasis that were exposed to BIMZELX, a total of 153 subjects were 65 years of age or older, and 18 subjects were 75 years of age or older. Although no differences in safety or effectiveness were observed between subjects 65 years of age or older and younger adult subjects, clinical trials in PSO did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects .

Of the 1,197 subjects with PsA that were exposed to BIMZELX, a total of 148 were 65 years of age and older. Although no differences in safety or effectiveness were observed between subjects 65 years of age or older and younger adult subjects, clinical trials in PsA did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects .

Of the 244 subjects with nr-axSpA that were exposed to BIMZELX, a total of 6 were 65 years of age and older. Although no differences in safety or effectiveness were observed between subjects 65 years of age or older and younger adult subjects, the clinical trial in nr-axSpA did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects .

Of the 330 subjects with AS that were exposed to BIMZELX, a total of 11 were 65 years of age and older. Although no differences in safety or effectiveness were observed between subjects 65 years of age or older and younger adult subjects, the clinical trial in AS did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects .

Of the 995 subjects with hidradenitis suppurativa that were exposed to BIMZELX, a total of 18 were 65 years of age and older. Although no differences in safety or effectiveness were observed between subjects 65 years of age or older and younger adult subjects, clinical trials in HS did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects .

The observed incidence of anti-drug antibodies (ADA) is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of ADA in the studies described below with the incidence of ADA in other studies, including those of BIMZELX or of other bimekizumab products.

Across the pivotal trials in all indications, there was no identified clinically significant effect of anti-bimekizumab-bkzx antibodies, including neutralizing anti-drug antibodies, on safety or effectiveness of BIMZELX.

None.

The following adverse reactions have been observed with BIMZELX and are discussed in greater detail in other sections of the labeling:

• Suicidal Ideation and Behavior [see Warnings and Precautions (5.1)]
• Infections [see Warnings and Precautions (5.2)]
• Liver Biochemical Abnormalities [see Warnings and Precautions (5.4)]
• Inflammatory Bowel Disease [see Warnings and Precautions (5.5)]

BIMZELX is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

This Instructions for Use contains information on how to inject BIMZELX.

Read this Instructions for Use before using the BIMZELX autoinjector and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

These instructions are for 1 injection only. You may need more than 1 injection at a time depending on your prescribed dose of BIMZELX. Each BIMZELX autoinjector is for one-time (single-dose) use only.

Important Information you Need to Know Before Injecting BIMZELX:

• Your healthcare provider should show you or a caregiver how to prepare and inject BIMZELX using the autoinjector for the first time. Do not inject yourself or someone else until you have been shown how to inject BIMZELX the right way. Call your healthcare provider if you have any questions.
• These instructions are for 1 injection only.
• The BIMZELX autoinjector has a needle safety feature that will be activated to cover the needle after the injection is finished. The needle safety feature will help to prevent needle stick injuries to anyone who handles the autoinjector after injection.
• Do notshare or reuse your BIMZELX autoinjector. You may give or get an infection.
• Do notremove the needle cap until just before you give the injection.
• If you have vision or hearing problems, do notuse the BIMZELX autoinjector without help from a caregiver.

How should I store BIMZELX autoinjector?

• Store the BIMZELX autoinjector in the refrigerator between 36°F to 46°F (2°C to 8°C).
• BIMZELX autoinjectors may be stored at room temperature up to 77°F (25°C) in the original carton for up to 30 days. Do notplace BIMZELX autoinjectors back in the refrigerator after they have been stored at room temperature.
• Write the date removed from the refrigerator in the space provided on the carton and throw away if it has been kept at room temperature and not used within 30 days.
• Keep BIMZELX in the original carton until ready for use to protect from light.
• Do not freeze BIMZELX.
• Do not shake BIMZELX.
• Do not use the BIMZELX autoinjector past the expiration date printed on the carton.

Keep BIMZELX autoinjectors and all medicines out of the reach of children.

BIMZELX autoinjector parts (see Figure A):

Supplies Needed for each BIMZELX injection

• 1 BIMZELX autoinjector. You may need 2 BIMZELX autoinjectors to give the prescribed dose.

Not provided in the BIMZELX autoinjector carton:

• 1 alcohol swab
• 1 clean cotton ball
• 1 sharps disposal container. See, " Step 12: Dispose of (throw away) the used BIMZELX autoinjector " at the end of this Instructions for Use.

Setting up for your BIMZELX injection.

Step 1: Take the BIMZELX autoinjector carton out of the refrigerator. Do notuse the BIMZELX autoinjector(s) if the carton seal is broken. Throw it away and get a new one.

• Keep the BIMZELX autoinjector in its original carton for 30 to 45 minutesto warm to room temperature. This will help to reduce discomfort when injecting.
  • Do notmicrowave the autoinjector, run hot water over it, or leave it in direct sunlight.
  • Do notshake the autoinjector.
  • Do nottake the cap off the autoinjector until you are ready to inject.

Step 2: Find a clean, flat, and well-lit work surface, like a table.

Step 3:Gather the supplies needed for your injection.

Step 4:Wash your hands well with soap and water and dry with a clean towel.

Step 5:Inspect the BIMZELX autoinjector (see Figure B):

• Remove the BIMZELX autoinjector from the carton.
• Make sure the name BIMZELX appears on the label.
  • Check the expiration date printed on the label.
  • Check the medicine through the Viewing Window. The medicine inside should be clear to slightly pearly, and colorless to pale brownish-yellow. You may see air bubble(s) in the liquid. This is normal.
• Do not use the BIMZELX autoinjector,throw it away and get a new one if:
  • The expiration date printed on the label has passed.
  • The medicine is cloudy, discolored, or has particles.
  • It looks damaged or has been dropped.

Choose and prepare your injection site.

Step 6: Choose and clean your injection site.

• The sites you may choose for your injection are:
  • your stomach area (abdomen) or your thigh (see Figure C ).
  • the back of your arm ( see Figure D ). BIMZELX may be injected into the back of your arm by a healthcare provider or caregiver only.

• Do notinject into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis , or within 2 inches of the belly button (navel).
• Choose a new injection site on the body each time you use BIMZELX. Do notuse the same injection site 2 times in a row.

Step 7: Prepare your skin

• Clean the injection site with an alcohol swab. Let the area dry completely. Do nottouch the cleaned area again before injecting.

Injecting BIMZELX.

Step 8: Remove the BIMZELX autoinjector cap.

• Hold the BIMZELX autoinjector firmly with one hand around the handle. Pull the cap straight off (away from) the autoinjector with the other hand ( see Figure E ). Although you cannot see the needle tip, it is now uncovered.
  • Putthe cap into an FDA-cleared sharps disposal container right away. You will not need it again.
  • Do nottouch the needle guard or put the cap back on as it could activate the autoinjector and you can stick yourself.

Step 9:Hold the BIMZELX autoinjector at a 90-degree angle to the cleaned injection site (see Figure F).

Step 10:Place the BIMZELX autoinjector flat against your skin, then firmly press the BIMZELX autoinjector down against your skin. You will hear a "click" sound. Your injection begins when the 1 ^st"click" is heard (see Figure G) .

• Do notlift the autoinjector away from the skin.

Keep holding the BIMZELX autoinjector in place and pressed firmly against your skin. It will take about 15 seconds to receive your full dose.

• You will hear a 2 ^nd"click" in about 15 seconds after you hear the first click.
• The second click tells you that all the medicine has been injected and your BIMZELX injection is finished. You should see the yellow color indicator filling the viewing window (see Figure H) .
• Important:When you remove the autoinjector, if the viewing window has not turned yellow this means you may not have received a full dose. Call your healthcare provider right away.

Step 11:Remove the BIMZELX autoinjector by carefully pulling the BIMZELX autoinjector straight up from your skin. The needle guard will automatically cover the needle. Do nottry to touch the needle.

• Press a clean cotton ball over the injection site for a few seconds. Do notrub the injection site. You may see slight bleeding or a drop of liquid. This is normal. You may cover the injection site with a small adhesive bandage, if needed.

Step 12: Dispose of (throw away) the used BIMZELX autoinjector (see Figure I).

• Put the used BIMZELX autoinjector in an FDA-cleared sharps disposal container right away after use. Do notthrow away (dispose of) the BIMZELX autoinjector in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
• Do notrecycle your used sharps disposal container.
  
  

Step 13: Repeat steps 1 through 12 with a new BIMZELX autoinjector if you need to use 2 autoinjectors to give the prescribed dose.

• Make sure you select a new injection site on the body each time you use BIMZELX. Do notuse the same site that you used for your first injection.

You can sign up to receive sharps containers for BIMZELX autoinjector disposal at no additional cost by going to www.BIMZELX.comor call 1-844-599-2273.

Manufactured by:

UCB, Inc. 1950 Lake Park Drive Smyrna, GA 30080

US License No. 1736

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Issued: 9/2024

Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin, and lesional skin in HS. Bimekizumab-bkzx exposure-response relationships to serum biomarkers, including IL-17A and IL-17F, and the time course of such pharmacodynamic responses are unknown.

Bimekizumab-bkzx pharmacokinetics are comparable in adult patients with moderate to severe plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis.

The median peak plasma concentration of bimekizumab-bkzx was 25 (range: 12-50) μg/mL and was reached in 3-4 days. Bimekizumab-bkzx exhibited dose-proportional pharmacokinetics in patients with plaque psoriasis over a dose range of 64 mg to 480 mg (0.2 to 1.5 times the approved recommended dosage) following subcutaneous administration.

The median steady-state trough concentration of bimekizumab-bkzx was approximately 40% lower in HS subjects than that of PSO subjects.

Three multicenter, randomized, double-blind trials [Trial Ps-1 (NCT03370133), Trial Ps-2 (NCT03410992), and Trial Ps-3 (NCT03412747)] enrolled a total of 1,480 subjects 18 years of age and older with moderate to severe plaque psoriasis who had a body surface area (BSA) involvement of ≥10%, an Investigator's Global Assessment (IGA) score of ≥3 ("moderate") in the overall assessment of psoriasis on a severity scale of 0 to 4, and a Psoriasis Area and Severity Index (PASI) score ≥12.

In Trial Ps-1, 567 subjects were randomized to receive either BIMZELX 320 mg by subcutaneous injection every 4 weeks, ustekinumab (for subjects weighing ≤100kg, 45 mg initially and 4 weeks later, then every 12 weeks; for subjects weighing >100kg, 90 mg initially and 4 weeks later, then every 12 weeks), or placebo through Week 52. At Week 16, subjects originally randomized to placebo received BIMZELX 320 mg every 4 weeks through Week 52.

In Trial Ps-2, 435 subjects were randomized to either BIMZELX 320 mg by subcutaneous injection every 4 weeks or placebo. At Week 16, subjects who achieved a PASI 90 response continued into a 40-week randomized withdrawal period. Subjects originally randomized to BIMZELX 320 mg every 4 weeks were re-randomized to either BIMZELX 320 mg every 4 weeks or BIMZELX 320 mg every 8 weeks or placebo. Subjects originally randomized to placebo continued to receive placebo if they were PASI 90 responders. Subjects who did not achieve a PASI 90 response at week 16 entered an open-label escape arm and received BIMZELX 320 mg every 4 weeks for 12 weeks. Subjects who relapsed, defined as having a less than PASI 75 response compared to baseline, during the randomized withdrawal period also entered the 12-week escape arm.

In Trial Ps-3, 478 subjects were randomized to receive either BIMZELX 320 mg by subcutaneous injection every 4 weeks through week 56, BIMZELX 320 mg every 4 weeks through week 16 followed by BIMZELX every 8 weeks through week 56, or adalimumab (80 mg as an initial dose followed by 40 mg every other week starting 1 week after initial dose through Week 24) followed by BIMZELX 320 mg every 4 weeks through Week 56.

In Trial Ps-1, Trial Ps-2, and Trial Ps-3, 71% of the subjects were male and 84% of the subjects were White, with a mean age of 45 years and a mean weight of 89 kg. At baseline, subjects had a median baseline PASI score of 18, median baseline for BSA of 20%, and baseline IGA score of 4 ("severe") in 33% of subjects. A total of 93% subjects had psoriasis of the scalp (Scalp IGA score of ≥1) and a total of 26% of subjects had a history of psoriatic arthritis. Additionally, 38% had received prior biologic therapy.

BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of:

• Moderate to severe plaque psoriasis (PSO)in adults who are candidates for systemic therapy or phototherapy. ( 1.1)
• Adults with active psoriatic arthritis (PsA). ( 1.2)
• Adults with active non-radiographic axial spondyloarthritis( nr-axSpA) with objective signs of inflammation. ( 1.3)
• Adults with active ankylosing spondylitis( AS). ( 1.4)
• Adults with moderate to severe hidradenitis suppurativa (HS). ( 1.5)

BIMZELX is indicated for the treatment of adults with active psoriatic arthritis.

Bimekizumab-bkzx is a humanized immunoglobulin IgG1/ κ monoclonal antibody with two identical antigen binding regions that selectively bind to human interleukin 17A (IL-17A), interleukin 17F (IL-17F), and interleukin 17-AF cytokines, and inhibits their interaction with the IL-17 receptor complex. IL-17A and IL-17F are naturally occurring cytokines that are involved in normal inflammatory and immune responses. Bimekizumab-bkzx inhibits the release of proinflammatory cytokines and chemokines.

The safety and efficacy of BIMZELX were assessed in 1,112 subjects in two multicenter, randomized, double-blind, placebo-controlled studies [Trial PsA-1 (NCT 03895203) and Trial PsA-2 (NCT 03896581)] in subjects 18 years and older with active psoriatic arthritis (PsA).

Subjects in these studies had a diagnosis of PsA of at least 6 months based on Classification Criteria for Psoriatic Arthritis (CASPAR), a median duration of 4.6 years at baseline, and active disease with ≥3 tender joint count and ≥3 swollen joint count. Subjects with each subtype of PsA were enrolled in these studies, including polyarticular symmetric arthritis (63.5%), oligoarticular asymmetric arthritis (25.9%), distal interphalangeal joint predominant (4.4%), spondylitis predominant (4.2%), and arthritis mutilans (1.5%). At baseline, 56% of subjects had ≥3% Body Surface Area (BSA) with active plaque psoriasis. At baseline across both studies, 32% and 12% of subjects had enthesitis and dactylitis, respectively, 58% of subjects had psoriatic nail disease, and 53% of subjects were receiving concomitant methotrexate.

The PsA-1 study evaluated 852 biologic-naïve subjects, who were treated with either BIMZELX 160 mg every 4 weeks up to Week 52, adalimumab 40 mg every 2 weeks up to Week 52 (active reference arm), or placebo. Subjects receiving placebo were switched to BIMZELX every 4 weeks at Week 16 to Week 52. In this study, 78% of subjects had received prior treatment with ≥ 1 conventional DMARDs (cDMARDs), and 22 % of subjects had no prior treatment with cDMARDs. At baseline, 58% of subjects were receiving concomitant methotrexate (MTX), 11% were receiving concomitant cDMARDs other than MTX, and 31% were receiving no cDMARDs. The PsA-2 study evaluated 400 anti-TNFα experienced subjects (inadequate response or intolerance to treatment), who were treated with BIMZELX 160 mg every 4 weeks or placebo up to Week 16. In this study, 43% of subjects were receiving concomitant MTX, 8% were receiving concomitant cDMARDs other than MTX, and 50% were receiving no cDMARDs.

For both studies, the primary endpoint was the proportion of subjects who achieved an America College of Rheumatology (ACR) 50 response at Week 16.

BIMZELX is indicated for the treatment of adults with active ankylosing spondylitis.

• Suicidal Ideation and Behavior (SI/B): May increase risk of SI/B. Advise patients, their caregivers, and families to monitor for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, instruct patients to promptly seek medical attention or call the National Suicide and Crisis Lifeline at 988. Carefully weigh risks and benefits of treatment with BIMZELX in patients with a history of severe depression and/or suicidal ideation or behavior. ( 5.1)
• Infections: May increase risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If such an infection develops, do not administer BIMZELX until the infection resolves. ( 5.2)
• Tuberculosis (TB): Avoid use in patients with active TB. Initiate treatment of latent TB prior to BIMZELX treatment. ( 5.3)
• Liver Biochemical Abnormalities: Elevated serum transaminases were reported in clinical trials. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline and according to routine patient management. Permanently discontinue use of BIMZELX in patients with causally - associated combined elevations of transaminases and bilirubin. ( 5.4)
• Inflammatory Bowel Disease (IBD): Cases of IBD were reported in clinical trials with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. Monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs. ( 5.5)
• Immunizations: Avoid the use of live vaccines in patients treated with BIMZELX. ( 5.6)

The efficacy and safety were assessed in 332 patients in one randomized, double-blind, placebo-controlled study [Trial AS-1 (NCT03928743)] in adult subjects 18 years of age and older with active ankylosing spondylitis. Subjects had to have documented radiologic evidence (x-ray) fulfilling the Modified New York criteria for AS. Subjects had active disease as defined by BASDAI ≥4 and spinal pain ≥4 on a 0 to 10 numeric rating scale (NRS) (from BASDAI Item 2). Subjects also had a history of inadequate response to 2 different non-steroidal anti-inflammatory drugs (NSAIDs), or intolerance or contraindication to NSAIDs. Approximately 20% of subjects were on concomitant cDMARDs. Overall, 16% of subjects had received previous treatment (failed or were intolerant to) with anti-TNF alpha agents.

Subjects were randomized 2:1 to receive BIMZELX 160 mg or placebo every 4 weeks up to the completion of Week 16 assessments. Starting at Week 16, all subjects received BIMZELX every 4 weeks up to Week 52. The primary endpoint was at least 40% improvement in Assessment of Spondyloarthritis International Society (ASAS 40) at Week 16.

• Prior to treatment: ( 2.1)
  
  
  • Evaluate patients for tuberculosis infection.
  • Test liver enzymes, alkaline phosphatase, and bilirubin.
  • Complete all age-appropriate vaccinations as recommended by current immunization guidelines.
• Plaque Psoriasis
  • Administer 320 mg by subcutaneous injection at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing 120 kg or more, consider a dose of 320 mg every 4 weeks after Week 16. ( 2.2)
• Psoriatic Arthritis
  • Administer 160 mg by subcutaneous injection every 4 weeks. ( 2.3)
  • For patients with coexisting moderate to severe plaque psoriasis, use the dosage and administration for plaque psoriasis. ( 2.2)
• Non-Radiographic Axial Spondyloarthritis
  • Administer 160 mg by subcutaneous injection every 4 weeks. ( 2.4)
• Ankylosing Spondylitis
  • Administer 160 mg by subcutaneous injection every 4 weeks. ( 2.5)
• Hidradenitis Suppurativa
  • Administer 320 mg by subcutaneous injection at Week 0, 2, 4, 6, 8, 10, 12, 14 and 16, then every 4 weeks thereafter. ( 2.6)
• See full prescribing information for recommendations regarding missed doses, preparation and administration instructions. ( 2.7, 2.8, 2.9)

BIMZELX is indicated for the treatment of adults with moderate to severe hidradenitis suppurativa.

• Before injecting, remove the carton with BIMZELX from the refrigerator and allow BIMZELX to reach room temperature (30 to 45 minutes) without removing the prefilled syringes or autoinjectors from the carton to protect from light.
• Inspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit. BIMZELX injection is clear to slightly opalescent, and colorless to pale brownish- yellow. Do not use if the solution contains visible particles, is discolored or cloudy.

• Injection: 160 mg/mL in a single-dose prefilled syringe or single-dose prefilled autoinjector. ( 3)
• Injection: 320 mg/2 mL (160 mg/mL) in a single-dose prefilled syringe or single-dose prefilled autoinjector. ( 3)

The following adverse reactions have been reported during post-approval use of BIMZELX. Because they are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Infections:conjunctivitis, esophageal candidiasis

The safety and efficacy of BIMZELX were assessed in two Phase 3 multicenter, randomized, double-blind, placebo-controlled trials [Trial HS-1 (NCT04242446) and Trial HS-2 (NCT04242498)] in 1,014 adult subjects with moderate to severe HS of at least 6 months with Hurley Stage II or Hurley Stage III disease, and with ≥5 inflammatory lesions [i.e., number of abscesses plus number of inflammatory nodules (AN count)], and a history of inadequate response to a course of systemic antibiotics for the treatment of HS.

Subjects received BIMZELX 320 mg every 2 weeks (Q2W) for 48 weeks, or BIMZELX 320 mg every 4 weeks (Q4W) up to Week 48, or BIMZELX 320 mg Q2W to Week 16, followed by 320 mg Q4W up to Week 48, or placebo. At Week 16, subjects receiving placebo were switched to BIMZELX 320 mg Q2W to Week 48. Concomitant oral doxycycline, minocycline, or an equivalent systemic tetracycline for HS was allowed if the subject was on a stable dose regimen for 28 days prior to baseline.

In these trials, at baseline the mean age of all subjects was 37 years, 57% of subjects were female, 80% were White, 11% were Black or African American, and 4% were Asian; for ethnicity, 7% identified as Hispanic or Latino. Of the subjects enrolled in trials conducted in the United States, 33% were Black or African American. The mean BMI was 33, and 46% were current smokers. Subjects had a median disease duration of 5 years. Overall, 9% of subjects were receiving concomitant antibiotic therapy for HS, and 19% of subjects had received previous treatment with biologics. The proportion of Hurley Stage II and Stage III subjects were 56% and 44%, respectively. Additionally, the mean number of draining tunnels was 3.6 and mean AN count was 16.3.

The primary efficacy endpoint in both trials was the Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16, defined by at least a 50% reduction in total abscess and inflammatory nodule count with no increase in abscess or draining tunnel count relative to baseline. Secondary endpoints included the proportion of subjects who achieved HiSCR75 and HS-specific skin pain response as assessed by a 0 to 10 numeric rating scale (NRS).

Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX [see Adverse Reactions (6.1)]. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

• BIMZELX is intended for use under the guidance and supervision of a healthcare professional. Patients may self-inject after training in subcutaneous injection technique. Provide proper training to patients and/or caregivers on the subcutaneous injection technique of BIMZELX according to the "Instructions for Use" [see Instructions for Use].
• If two separate 160 mg injections are used to achieve the recommended dose, administer each injection subcutaneously at a different anatomic location (such as thighs, abdomen or back of upper arm). Discard the syringes or autoinjectors after use. Do not reuse.
• Do not inject BIMZELX within 2 inches (5 cm) of the navel or into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis. Administration of BIMZELX in the upper, outer arm may only be performed by a healthcare professional or caregiver. Rotate the injection site with each injection.

Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

An increased incidence of new onset or worsening suicidal ideation and behavior was observed in subjects treated with BIMZELX. A causal association between treatment with BIMZELX and increased risk of suicidal ideation and behavior has not been definitively established.

Suicidal ideation and behavior were prospectively monitored using the Columbia Suicide Severity Rating Scale (C-SSRS) in clinical trials. The C-SSRS is an interview-based instrument used to monitor for the presence and severity of suicidal ideation (ranging from "none" to "active suicidal ideation with specific plan and intent") and behaviors (rating the injury and potential lethality of self-injury, if present).

Treatment with BIMZELX was associated with increased incidence of liver enzyme elevations compared to treatment with placebo in randomized clinical trials. Liver serum transaminase elevations > 3 times the upper limit of normal were reported in subjects treated with BIMZELX [see Adverse Reactions (6.1)] . Elevated liver serum transaminases resolved after discontinuation of BIMZELX.

Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with BIMZELX and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded. Permanently discontinue BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Patients with acute liver disease or cirrhosis may be at increased risk for severe hepatic injury; avoid use of BIMZELX in these patients.

The recommended dosage is 320 mg by subcutaneous injection at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter .For patients weighing 120 kg or more, consider a dosage of 320 mg every 4 weeks after Week 16 [see Clinical Pharmacology (12.3)] .

BIMZELX is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.

The efficacy and safety were assessed in 254 patients in one randomized, double-blind, placebo-controlled study [Trial nr-axSpA-1 (NCT03928704)] in adult subjects 18 years of age and older with active non-radiographic axial spondyloarthritis. Subjects had to have objective signs of inflammation with elevated C-reactive protein (CRP) level and/or evidence of sacroiliitis on Magnet Resonance Imaging (MRI). Subjects met ASAS classification criteria for axial spondyloarthritis and have active disease as defined by BASDAI greater than or equal to 4, spinal pain of greater than or equal to 4 (0-10 numeric rating scale (NRS)), and no definitive radiographic evidence of structural damage in the sacroiliac joints. At baseline, 73% of subjects had enthesitis. Subjects also had a history of inadequate response to 2 different non-steroidal anti-inflammatory drugs (NSAIDs), or intolerance or contraindication to NSAIDs. Approximately 24% of subjects were on concomitant cDMARDs. Overall, 11% of subjects had received previous treatment (failed or were intolerant to) with anti-TNF alpha agents.

Subjects were randomized to receive BIMZELX 160 mg or placebo every 4 weeks up to the completion of Week 16 assessments. Starting at Week 16, all subjects received BIMZELX every 4 weeks up to Week 52. The primary endpoint was at least 40% improvement in Assessment of Spondyloarthritis International Society (ASAS 40) at Week 16.

The recommended dosage is 160 mg by subcutaneous injection every 4 weeks.

For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosing regimen for adult patients with plaque psoriasis [see Dosage and Administration (2.2)] .

The recommended dosage is 160 mg by subcutaneous injection every 4 weeks.

NDC 50474-780-79

Rx ONLY

ATTENTION: Dispense enclosed

Medication Guide to each patient.

Bimzelx ^®

(bimekizumab-bkzx) Injection

160 mg/mL per syringe

FOR SUBCUTANEOUS USE ONLY

Two single-dose prefilled

syringes. Each syringe

delivers 160 mg in 1 mL

of bimekizumab-bkzx.

For a 320 mg dose, two 160 mg

prefilled syringes are required.

The recommended dosage is 320 mg by subcutaneous injection at Weeks 0, 2, 4, 6, 8, 10, 12, 14, and 16, then every 4 weeks thereafter.

NDC 50474-783-78

Rx ONLY

ATTENTION: Dispense enclosed

Medication Guide to each patient.

Bimzelx ^®

(bimekizumab-bkzx) Injection

320 mg/2 mL (160 mg/mL)

syringe

FOR SUBCUTANEOUS USE ONLY

One single-dose prefilled syringe.

Each syringe delivers 320 mg

in 2 mL of bimekizumab-bkzx.

NDC 50474-781-85

Rx ONLY

ATTENTION: Dispense enclosed

Medication Guide to each patient.

Bimzelx ^®

(bimekizumab-bkzx) Injection

160 mg/mL per autoinjector

FOR SUBCUTANEOUS USE ONLY

Two single-dose autoinjectors.

Each autoinjector delivers 160 mg

in 1 mL of bimekizumab-bkzx.

For a 320 mg dose, two 160 mg

autoinjectors are required.

Carcinogenicity and mutagenicity studies have not been conducted with bimekizumab-bkzx.

No effects on fertility parameters such as effects on reproductive organs, menstrual cycle length, or sperm analysis were observed in sexually mature cynomolgus monkeys that were subcutaneously administered 200 mg/kg/week bimekizumab-bkzx (150 times the MRHD, based on mg/kg comparison) for 26 weeks. The monkeys were not mated to evaluate fertility.

NDC 50474-782-84

Rx ONLY

ATTENTION: Dispense enclosed

Medication Guide to each patient.

Bimzelx ^®

(bimekizumab-bkzx) Injection

320 mg/2 mL autoinjector

FOR SUBCUTANEOUS USE ONLY

One single-dose autoinjector.

Each autoinjector delivers 320 mg

in 2 mL of bimekizumab-bkzx.

The recommended dosage is 160 mg by subcutaneous injection every 4 weeks.

• Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX [see Warnings and Precautions (5.3)] .
• Test liver enzymes, alkaline phosphatase and bilirubin prior to initiating treatment with BIMZELX [see Warnings and Precautions (5.4)] .
• Complete all age-appropriate vaccinations as recommended by current immunization guidelines [see Warning and Precautions (5.6)] .