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FDA approves Bimzelx (bimekizumab-bkzx)

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On October 18, 2023, the US Food and Drug Administration approved Bimzelx (bimekizumab-bkzx) for the treatment of moderate to severe plaque psoriasis  in adults who are candidates for systemic therapy or phototherapy. [1] Bimekizumab is a humanized IgG1 kappa antibody that selectively inhibits IL-17A and IL-17F by binding regions that are common to these pro-inflammatory cytokines, which share ~50% sequence identity and are expressed as homodimers and IL-17A/F heterodimers. Bimekizumab is approved at a recommended dose of 320 mg, administered by two subcutaneous injections of 160 mg each every four weeks to week 16 and every eight weeks thereafter.

The approval of bimekizumab is supported by data from two Phase 3 studies that compared the effects of bimekizumab to those of either ustekinumab (Stellara®; BE VIVID study; NCT03370133) or adalimumab (Humira®; BE SURE study; NCT03412747) in adults with moderate to severe plaque psoriasis. These pivotal studies met their co-primary endpoints at Week 16, demonstrating superiority of bimekizumab over the active comparator in certain defined measures (e.g., Psoriasis Area and Severity Index). Clinical responses achieved with bimekizumab at Week 16 were maintained up to one year. [2-3] Coprimary endpoints were also met in the Phase 3 BE READY study (NCT03410992), which investigated the efficacy and safety of bimekizumab in patients with moderate to severe plaque psoriasis compared to placebo. [4]

  1. UCB. BIMZELX[®] Approved by the U.S. FDA for the Treatment of Adults with Moderate to Severe Plaque Psoriasis.
  2. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo-controlled phase 3 trial. Lancet. 2021;397(10273):487-498.
  3. Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021;385(2):130-141.
  4. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486.