FDA Approves Bimekizumab-bkzx (Bimzelx) for 3 New Rheumatic Indications

The most common adverse reactions in the nr-axSpA clinical trial were cough, diarrhea, headache, fatigue, musculoskeletal pain, myalgia, oral candidiasis, tonsilitis, transaminase increase, urinary tract infection and upper respiratory tract infections. The most common adverse reactions in the AS clinical trial were diarrhea, headache, injection site pain, oral candidiasis, rash, upper respiratory tract infections and vulvovaginal mycotic infection.

No new safety signals for bimekizumab-bkzx were identified. Clinicians should review important safety information in the product labeling prior to prescribing the agent.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. UCB announces U.S. FDA approvals for Bimzelx (bimekizumab-bkzx) for the treatment of psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis [news release]. UCB’s Global Corporate website. 2024 Sep 23.
2. Highlights of prescribing information: Bimzelx (bimekizumab-bkzx) injection. U.S. Food & Drug Administration. 2023 Oct.
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