FDA Approves Bimekizumab for Moderate-To-Severe Plaque Psoriasis

The FDA has approved bimekizumab-bkzx (Bimzelx; UCB) for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Bimekizumab is a novel, humanized monoclonal IgG1 antibody that potently and selectively neutralizes both IL-7A and IL-17F, which are key cytokines driving inflammatory processes. It is the first and only approved psoriasis treatment that selectively inhibits these cytokines.

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“We know that completely clear skin is valued by people with psoriasis and, in our phase 3 trials, at week 16, 85%-91% of patients treated with Bimzelx achieved clear or almost clear skin, with 59-68% achieving the goal of complete clearance,” said Emmanuel Caeymaex, executive vice president, immunology Solutions and head of US, UCB, in a press release. “With Bimzelx now approved for psoriasis, we will move forward rapidly to submit applications for additional indications in the US.”

The FDA based the approval of bimekizumab on findings from a trio of phase 3, multicenter, randomized, placebo and/or active comparator-controlled trials—BE READY, BE VIVID, and BE SURE—which analyzed the efficacy and safety of the drug in 1480 adults with moderate-to-severe plaque psoriasis. All of the trials met the co-primary endpoint and all ranked secondary endpoints, according to UCB.

Patients administered bimekizumab achieved superior levels of skin clearance at week 16 compared with patients administered ustekinumab (ranked secondary endpoint, BE VIVID; p<0.0001), placebo (co-primary endpoint, BE READY and BE VIVID; p<0.0001), and adalimumab (co-primary endpoint, BE SURE; p<0.001), as measured by at least a 90% improvement in the Psoriasis Area & Severity Index (PASI 90) and an Investigator’s Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1), according to UCB. Key secondary endpoints included PASI 75 at week 4 and PASI 100 at week 16.

Further, more than 8 in 10 patients administered bimekizumab at a dose of 320 mg every 4 weeks [Q4W] achieved PASI 90 and IGA 0/1 at week 16. Approximately 6 in 10 patients administered bimekizumab at a dose of 320 mg Q4W achieved PASI 100 at week 16 and more than 7 of 10 patients achieved PASI 75 at week 4 following a single 320 mg dose.

“We have been eagerly awaiting bimekizumab, the first IL-17A and IL-17F inhibitor, to be approved in the US. for the treatment of adults with moderate-to-severe plaque psoriasis. In phase 3/3b trials, bimekizumab achieved superior levels of skin clearance at week 16 compared to placebo and three existing biologics for psoriasis, with responses being rapid and lasting up to a year. Long-term data have also shown that the majority of patients maintained high levels of clinical response through 3 years,” said bimekizumab investigator Mark Lebwohl, MD, dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai, and Chairman Emeritus, Kimberly and Eric J. Waldman Department of Dermatology, in a press release.

The most common adverse events associated with bimekizumab (≥ 1%) were upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other Candida infections, and fatigue.

The recommended dosage of bimekizumab for patients with psoriasis is 320 mg administered as 2 subcutaneous injections of 160 mg each at weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. The drug can be administered by a health care professional or by patients via self-injection after proper training. Bimekizumab is expected to be available in the United States in approximately 1 month.

“The approval of bimekizumab will provide an important new treatment option for adults living with moderate-to-severe plaque psoriasis,” said Leah McCormick Howard, JD, president and CEO for the National Psoriasis Foundation, in a press release. “Our hope is that new treatments translate into improved outcomes for many and help alleviate the physical and emotional burden of psoriasis.”

Reference

BIMZELX Approved by the U.S. FDA for the Treatment of Adults with Moderate-to-Severe Plaque Psoriasis. UCB. News release. October 18, 2023. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/bimzelx-approved-by-the-us-fda-for-the-treatment-of-adults-with-moderate-to-severe-plaque-psoriasis