FDA Approves UCB's BIMZELX® for Moderate to Severe Hidradenitis Suppurativa

On November 20, 2024, UCB, a global biopharmaceutical company based in Brussels, Belgium, 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). This approval marks a significant milestone as bimekizumab-bkzx is the first and only treatment specifically designed to selectively inhibit both interleukin 17F (IL-17F) and interleukin 17A (IL-17A).

Dr. Alexa B. Kimball, an investigator and lead author of the studies from Beth Israel Deaconess Medical Center and Harvard Medical School, commented on the approval, emphasizing the substantial unmet clinical needs and limited treatment options currently available for patients with HS. She noted that in Phase 3 clinical studies, patients treated with bimekizumab-bkzx demonstrated deep and sustained clinical responses for up to 48 weeks.

Hidradenitis suppurativa is a chronic, recurrent, and painful inflammatory skin condition characterized by nodules, abscesses, and pus-discharging fistulas, primarily affecting areas such as the armpits, groin, and buttocks. The disease significantly impacts the quality of life due to its flare-ups and severe pain.

Brindley Brooks, Founder and Executive Director of HS Connect in the U.S., expressed optimism about the new treatment option, highlighting the potential for improved care and reduced stigma for individuals with moderate to severe HS in the U.S.

The FDA approval of bimekizumab-bkzx is based on data from two Phase 3 studies, BE HEARD I and BE HEARD II. These studies evaluated the efficacy and safety of the drug in adults with moderate to severe HS. The results revealed that a significantly higher proportion of patients treated with bimekizumab-bkzx achieved a 50 percent or greater improvement in HS signs and symptoms at Week 16 compared to placebo, as measured by HiSCR50, the primary endpoint in both trials. Additionally, the treatment showed clinically meaningful improvements in the key secondary endpoint, HiSCR75, versus placebo at Week 16, with sustained clinical responses observed through Week 48. The safety profile of bimekizumab-bkzx was consistent with previous trial data, with no new safety concerns identified.

Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact and Chief Commercial Officer at UCB, celebrated this milestone, noting that BIMZELX is now approved for its fifth patient population in the U.S., representing a significant advancement in their mission to address immune-mediated inflammatory diseases. He reiterated UCB's commitment to innovation and raising standards of care in hidradenitis suppurativa and other immunological conditions.

Prior to this, bimekizumab-bkzx was approved in the U.S. in October 2023 for the treatment of moderate to severe plaque psoriasis in adults. The drug has also received recent FDA approvals for the treatment of adults with active psoriatic arthritis, active non-radiographic axial spondyloarthritis with objective signs of inflammation, and active ankylosing spondylitis.

BE HEARD I and BE HEARD II were randomized, double-blind, placebo-controlled, parallel group, multicenter Phase 3 studies designed to assess the efficacy and safety of bimekizumab-bkzx in adults with moderate to severe HS. These studies included a combined total of 1,014 participants diagnosed with moderate to severe HS. The primary endpoint for both studies was HiSCR50 at Week 16, and secondary endpoints included HiSCR75 and HS-specific skin pain response at Week 16. Detailed results from these studies have been published in The Lancet.

Bimekizumab-bkzx is a humanized IgG1 monoclonal antibody that targets IL-17A, IL-17F, and IL-17AF cytokines, inhibiting their interaction with the IL-17RA/IL-17RC receptor complex. UCB remains dedicated to transforming the lives of individuals with severe diseases of the immune system through innovative medical solutions.