FDA Approves BIMZELX for Moderate-to-Severe Hidradenitis Suppurativa

November 26, 2024

November 26, 2024
Tags: BIMZELEX, FDA News, hidradenitis suppurativa
Original Article
Article, Hidradenitis Suppurativa

UCB recently announced that the U.S. Food and Drug Administration (FDA) has approved BIMZELX ® (bimekizumab-bkzx) for the treatment of moderate-to-severe hidradenitis suppurativa (HS) in adults.

This approval is significant as BIMZELX is the first and only treatment specifically designed to selectively inhibit both interleukin 17F (IL-17F) and interleukin 17A (IL-17A). Its approval represents a major advancement in addressing the unmet needs of HS patients, providing a novel therapeutic option for this chronic and painful condition.

Support for this approval was based on robust data from two pivotal Phase 3 studies, BE HEARD I and BE HEARD II, which evaluated the safety and efficacy of BIMZELX in adults with moderate-to-severe HS. Results demonstrated that a significantly higher proportion of patients treated with BIMZELX achieved a 50% or greater improvement in HS symptoms and signs (HiSCR50) compared to placebo at Week 16, the primary endpoint for both studies.

Additionally, BIMZELX delivered clinically meaningful improvements in the key secondary endpoint, HiSCR75, with more patients achieving a 75% reduction in symptoms compared to placebo at Week 16. These improvements were sustained through Week 48. The safety profile of BIMZELX in these studies was consistent with findings from previous clinical trials across other indications, with no new safety signals observed.

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, Massachusetts, commented, “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. In the Phase 3 clinical studies, patients treated with bimekizumab-bkzx achieved deep and sustained clinical responses up to 48 weeks.”

This FDA approval is the fifth indication for BIMZELX in the U.S., following its prior approvals for conditions such as moderate-to-severe plaque psoriasis, active psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis.

Speaking on this milestone, Christopher G. Bunick, MD, PhD, LiVDerm Advisory Board Member and associate professor of dermatology and translational biomedicine at the Yale University School of Medicine in New Haven, Connecticut, said, “The approval of bimekizumab is a landmark step in the treatment of hidradenitis suppurativa using multi-targeted biologics. Neutralization of Il-17A and Il-17F, the science of which was published earlier this year in JID, will raise the standards of care for HS patients and deliver much needed clinical, psychological, and social improvements.”

This milestone represents a transformative moment for both patients and healthcare providers, enabling access to an innovative, targeted therapy to manage a challenging condition.

Reaffirming their commitment to addressing unmet medical needs, Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, and Chief Commercial Officer at UCB, stated, “We are thrilled that with this milestone BIMZELX is now FDA-approved for the treatment of adults with moderate-to-severe hidradenitis suppurativa, a chronic and painful disease affecting approximately one in 100 people. This is the fifth patient population who may benefit from BIMZELX in the U.S., representing a significant step forward in our mission to alleviate the global burden of immune-mediated inflammatory diseases. This progress underscores our commitment to addressing unmet needs in hidradenitis suppurativa and other immunological conditions, delivering innovative medicines, and raising standards of care.”