UCB's Bimzelx (bimekizumab-bkzx) has received FDA approval for treating adults with moderate to severe hidradenitis suppurativa (HS), marking a significant advancement in the therapeutic landscape for this chronic inflammatory skin condition. This approval makes bimekizumab-bkzx the first and only FDA-approved medicine designed to selectively inhibit both interleukin 17F (IL-17F) and interleukin 17A (IL-17A). The approval is based on robust data from two Phase 3 clinical trials, BE HEARD I and BE HEARD II, demonstrating the drug's efficacy and safety in this patient population.
Clinical Trial Data
The FDA's decision was supported by data from the BE HEARD I and BE HEARD II trials, which evaluated bimekizumab-bkzx in adults with moderate to severe HS. These studies, involving a combined enrollment of 1,014 participants, were randomized, double-blind, placebo-controlled, parallel-group, and multicenter in design. The primary endpoint in both studies was HiSCR50 at Week 16, defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
Results from the trials indicated that a significantly higher proportion of patients treated with bimekizumab-bkzx achieved HiSCR50 at Week 16 compared to those receiving placebo. Furthermore, bimekizumab-bkzx treatment led to clinically meaningful improvements in HiSCR75, a key secondary endpoint, also at Week 16. The clinical responses were sustained through Week 48. The safety profile of bimekizumab-bkzx in these trials was consistent with previous studies across different indications, with no new safety signals identified. Detailed results from BE HEARD I and BE HEARD II have been published in The Lancet.
Hidradenitis Suppurativa: An Unmet Need
Hidradenitis suppurativa is a chronic, recurring, painful, and potentially debilitating inflammatory skin disease affecting approximately one in 100 people. The condition is characterized by nodules, abscesses, and pus-discharging fistulas, typically occurring in the armpits, groin, and buttocks. Patients with HS experience flare-ups and severe pain, significantly impacting their quality of life. Alexa B. Kimball, MD, MPH, Beth Israel Deaconess Medical Center and Professor of Dermatology, Harvard Medical School, noted the substantial unmet clinical needs and limited treatment options currently available for HS.
Bimekizumab-bkzx: Mechanism of Action
Bimekizumab-bkzx is a humanized IgG1 monoclonal antibody that selectively binds to IL-17A, IL-17F, and IL-17AF cytokines, blocking their interaction with the IL-17RA/IL-17RC receptor complex. This dual inhibition differentiates it from other IL-17 inhibitors and may contribute to its efficacy in treating HS.
Previous Approvals and Future Implications
This FDA approval marks the fifth patient population in the U.S. that may benefit from Bimzelx. Bimekizumab-bkzx has previously been approved for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, active non-radiographic axial spondyloarthritis, and active ankylosing spondylitis. This latest approval underscores UCB's commitment to addressing unmet needs in hidradenitis suppurativa and other immunological conditions, delivering innovative medicines, and raising standards of care.
