U.S. FDA Approval for BIMZELX® (bimekizumab-bkzx) for Adults with Moderate-to-Severe Hidradenitis Suppurativa

发布时间： 2024-11-28 阅读：204次

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November 21, 2024 – UCB announced that the U.S. Food and Drug Administration (FDA) has approved BIMZELX® (bimekizumab-bkzx) for the treatment of adults with moderate-to-severe hidradenitis suppurativa (HS).1 BIMZELX is the first and only approved medicine designed to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A). The milestone marks the fifth indication for BIMZELX in the U.S.

The approval is supported by data from two Phase 3 studies, BE HEARD I and BE HEARD II, which evaluated the efficacy and safety of BIMZELX in the treatment of adults with moderate-to-severe HS. Results showed that a higher proportion of patients treated with BIMZELX 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. BIMZELX 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 BIMZELX was consistent with safety data seen in previous trials across indications with no new safety signals.4 Detailed results from BE HEARD I and BE HEARD II have been published in The Lancet.

This FDA approval of BIMZELX for the treatment of adults with moderate-to-severe hidradenitis suppurativa follows its recent approvals for the treatment of adults with active psoriatic arthritis, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation, and adults with active ankylosing spondylitis. BIMZELX was first approved in the U.S. in October 2023, for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.