Bimekizumab FDA Approved for Moderate to Severe Hidradenitis Suppurativa

The US Food and Drug Administration has approved UCB’s BIMZELX (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS). This approval makes bimekizumab the first and only dual interleukin-17A (IL-17A) and interleukin-17F (IL-17F) inhibitor available for HS, offering a new treatment option for a chronic and debilitating inflammatory skin condition. 

Bimekizumab is administered as an injection and has demonstrated significant improvements in HS symptoms, such as nodules, abscesses, and fistulas, while also addressing the associated severe pain. Approval was based on 2 Phase 3 clinical trials, BE HEARD I and BE HEARD II, which showed that patients treated with bimekizumab achieved a 50% or greater improvement in HS signs and symptoms (HiSCR50) at week 16, with benefits sustained through week 48. These trials also demonstrated clinically meaningful improvements in HS clinical response 75 (HiSCR75), a key secondary endpoint, highlighting the durability of response. 

Dr Alexa B. Kimball, a lead investigator in the trials, noted the significance of this approval, stating, “Patients treated with bimekizumab-bkzx achieved deep and sustained clinical responses up to 48 weeks. This represents a meaningful step forward for the hidradenitis suppurativa community.” 

Bimekizumab's safety profile in HS was consistent with previous clinical trials across other indications, with no new safety concerns identified. This approval represents the fifth indication for bimekizumab in the United States, following approvals for plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis. 

Brindley Brooks, executive director of HS Connect, welcomed the development, stating, “Today’s approval offers a new possibility for the treatment of people in the US living with moderate to severe disease, giving hope to the hidradenitis suppurativa community.” 

Emmanuel Caeymaex, executive vice president at UCB, emphasized the company’s commitment, adding, “This milestone underscores our dedication to alleviating the burden of immune-mediated inflammatory diseases and raising the standard of care for patients.” 

Bimekizumab’s dual inhibition of IL-17A and IL-17F continues to expand its potential as an innovative treatment for immune-mediated diseases, offering new hope to patients with challenging conditions like HS.

Reference

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. Press Release. UCB. 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