FDA approves Bimzelx (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa – UCB

UCB,  announced that the FDA has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS). Bimekizumab-bkzx is the first and only approved medicine designed to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A).

“The approval of Bimzelx in moderate to severe hidradenitis suppurativa is welcome given the substantial unmet clinical needs and limited number of treatment options available today,” said investigator and lead author of the studies, Alexa B. Kimball, MD, MPH, Beth Israel Deaconess Medical Center and Professor of Dermatology, Harvard Medical School, Boston, MA, U.S. “In the Phase III clinical studies, patients treated with bimekizumab-bkzx achieved deep and sustained clinical responses up to 48 weeks.”

Hidradenitis suppurativa is a chronic, recurring, painful and potentially debilitating inflammatory skin disease. The main symptoms are nodules, abscesses and pus-discharging fistulas, i.e., channels leading out of the skin, typically in the armpits, groin and buttocks. People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.

The approval is supported by data from two Phase III studies, BE HEARD I and BE HEARD II, which evaluated the efficacy and safety of bimekizumab-bkzx in the treatment of adults with moderate to severe HS.  Results showed that a higher proportion of patients treated with bimekizumab-bkzx vs. placebo achieved a 50 percent or greater improvement in HS signs and symptoms at Week 16, as measured by HiSCR50, the primary endpoint in both trials.  Bimekizumab-bkzx treatment also resulted in clinically meaningful improvements in the key ranked secondary endpoint, HiSCR75, vs. placebo at Week 16. Clinical responses were sustained to Week 48. The safety profile of bimekizumab-bkzx was consistent with safety data seen in previous trials across indications with no new safety signals. Detailed results from BE HEARD I and BE HEARD II have been published in The Lancet.

Citation::Kimball AB, Jemec GBE, Sayed CJ, et al. “Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48 week, randomised, double blind, placebo controlled, multicentre phase III trials.” Lancet. 2024;403(10443):2504-19