FDA Approves Bimekizumab for Adults with Moderate to Severe HS

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UCB announced today the FDA approval of bimekizumab-bkzx (Bimzelx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS). The therapy is the first approved for HS that selectively inhibits both interleukin (IL)-17A and IL-17F, marking a shift in the management of this chronic and often debilitating skin condition.¹ 

“The approval of BIMZELX in moderate to severe HS 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, Massachusetts, in a news release. “In the phase 3 clinical studies, patients treated with bimekizumab-bkzx achieved deep and sustained clinical responses up to 48 weeks.”

Dual IL-17 Inhibition

By inhibiting IL-17A and IL-17F, cytokines critical to the inflammatory processes underlying HS, bimekizumab offers a dual approach to modulating immune responses. The company stated this targeted action addresses the chronic inflammation and tissue destruction hallmarking HS, providing a novel treatment option that meets the disease’s multifaceted pathophysiology.

“The approval of bimekizumab is a landmark step in the treatment of hidradenitis suppurativa using multi-targeted biologics," said Christopher Bunick, MD, PhD, associate professor of dermatology and translational biomedicine at the Yale University School of Medicine in New Haven, Connecticut, and Dermatology Times’ 2024 Winter Editor in Chief.

“Neutralization of Il-17A and Il-17F, the science of which was published earlier this year in JID,² will raise the standards of care for HS patients and deliver much needed clinical, psychological, and social improvements,” Bunick said.

Efficacy and Safety

The approval of bimekizumab is supported by robust evidence from the pivotal phase 3 trials, BE HEARD I and BE HEARD II. These randomized, double-blind, placebo-controlled studies evaluated the efficacy and safety of bimekizumab in adults with moderate to severe HS. Key findings include:

• Primary Endpoint Achievement: At week 16, researchers found a significantly greater proportion of patients receiving bimekizumab achieved HS Clinical Response (HiSCR) 50 (≥50% reduction in inflammatory nodule and abscess count with no increase in draining fistulas) compared to placebo.
• Sustained Responses: Clinical improvements, as evidenced by HiSCR75 (≥75% reduction in HS signs and symptoms), were sustained through week 48.
• Safety Profile: The company stated bimekizumab exhibited a favorable safety profile, consistent with previous clinical trials. No new safety signals emerged during the study period. 

“We are working toward a world where people with HS live without stigma, feel widely understood, and are treated effectively. Today’s approval of bimekizumab-bkzx is an exciting time for the HS community, offering a new possibility for the treatment of people in the US living with moderate to severe disease,” said Brindley Brooks, Founder and Executive Director, HS Connect, US, in the release.

Bimekizumab’s approval for HS represents its fifth FDA-sanctioned indication, following prior approvals for conditions such as moderate to severe plaque psoriasis, active psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis.³

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

Conclusion

The approval of bimekizumab for moderate to severe HS represents the first therapy of its kind indicated for treatment of the condition. For clinicians, this novel therapy offers a powerful tool to combat a challenging disease, which can lead to improved outcomes and enhanced quality of life for patients.

References

1. UCB receives US FDA approval for BIMZELX® (bimekizumab-bkzx) as the first IL-17A and IL-17F inhibitor for adults with moderate-to-severe hidradenitis suppurativa. News Release. UCB. Published November 20, 2024. Accessed November 20, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-receives-us-fda-approval-for-bimzelxr-bimekizumab-bkzx-as-the-first-il-17a-and-il-17f-inhibitor-for-adults-with-moderate-to-severe-hidradenitis-suppurativa
2. Adams R, Bunick CG, Lawson ADG, Gomez B, Shaw S. Crystal structure of bimekizumab fab fragment in complex with IL-17F provides molecular basis for dual IL-17A and IL-17F inhibition. J Invest Dermatol. 2024;144(11):2581-2583.e2. doi:10.1016/j.jid.2024.03.037
3. BIMZELX® (bimekizumab-bkzx) US prescribing information. Accessed November 20, 2024. https://www.ucb-usa.com/Innovation/Products/BIMZELX.