FDA Approves Bimekizumab for Moderate to Severe Plaque Psoriasis

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The US Food and Drug Administration (FDA) has approved bimekizumab (BIMZELX, UCB) for the treatment of adults with moderate to severe plaque psoriasis¹ who are also candidates for phototherapy or systemic therapy, making bimekizumab the first and only approved IL-17A and IL-17F inhibitor for this indication.

The approval comes after positive phase 3 data from the BE READY, BE VIVID, and BE SURE trials evaluating the safety and efficacy of bimekizumab in 1,480 adults with moderate to severe plaque psoriasis. All studies met their primary and secondary endpoints.

Within these trials, 85% to 91% of patients treated with bimekizumab achieved clear or almost clear skin at week 16. Approximately 59% to 68% of bimekizumab-treated patients achieved complete clearance. Following just one dose, more than 7 in 10 patients achieved a Psoriasis Area and Severity Index (PASI) score of 75 by week 4 of treatment with bimekizumab.

"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 three years,” said Mark Lebwohl, MD, in a press release from UCB.¹ Lebwohl is a bimekizumab investigator, dean for clinical therapeutics at the Icahn School of Medicine at Mount Sinai, and chairman emeritus of the Kimberly and Eric J. Waldman Department of Dermatology.

The approval marks an exciting advancement for dermatology professionals and psoriasis patients alike.

“I am absolutely thrilled for psoriasis patients that the US FDA has finally approved Bimzelx for adult patients suffering from moderate to severe plaque psoriasis," Christopher Bunick, MD, PhD, a board-certified dermatologist, associate professor of dermatology, and physician-scientist at the Yale School of Medicine, told Dermatology Times.

"The unique mechanism of action of Bimzelx allows dual neutralization of IL-17A and IL-17F, and dermatologists and psoriasis patients are now going to see first hand the rapid, powerful, and durable skin clearance Bimzelx has to offer from that extra IL-17F inhibition, as was apparent in phase 3 clinical trial results," Bunick said. "It hopefully is only a short time before it is also approved for psoriatic arthritis, a devastating manifestation of psoriasis that is under treated. Overall, a celebratory day for dermatology and psoriasis patients."

Leah Howard, JD, president and CEO of the National Psoriasis Foundation, said,¹ “The approval of bimekizumab will provide an important new treatment option for adults living with moderate to severe plaque psoriasis. Our hope is that new treatments translate into improved outcomes for many and help alleviate the physical and emotional burden of psoriasis.”

Bimekizumab is expected to be available in the US in approximately 1 month and will be available as a pre-filled syringe or autoinjector to be administered either by a health care professional or via self-injection. The FDA-recommended dosage is 320 mg injected subcutaneously in 2 160 mg injections at weeks 0, 4, 8, 12, 16, and every 8 weeks after, with adjusted considerations for patients weighing equal to or greater than 120 kg.

Reference

1. BIMZELX approved by the U.S. FDA for the treatment of adults with moderate to severe plaque psoriasis. UCB. October 18, 2023. Accessed October 18, 2023. https://www.ucb.com/stories-media/Press-Releases/article/BIMZELXR-Approved-by-the-US-FDA-for-the-Treatment-of-Adults-with-Moderate-to-Severe-Plaque-Psoriasis