FDA Approves Bimzelx (bimekizumab-bkzx) for Moderate-to-Severe Hidradenitis Suppurativa

• The FDA has approved Bimzelx (bimekizumab-bkzx) for treating moderate-to-severe hidradenitis suppurativa (HS) in adults, offering a new treatment option.
• Bimzelx is the first treatment of its kind, selectively inhibiting both IL-17A and IL-17F, providing a novel approach to managing this inflammatory skin condition.
• Clinical trials demonstrated that Bimzelx achieved significant and sustained clinical responses in patients with HS over a 48-week period.
• Data presented at ACR Convergence 2024 highlighted Bimzelx's sustained efficacy in treating psoriatic arthritis and axial spondyloarthritis over two years.

The U.S. Food and Drug Administration (FDA) has approved Bimzelx (bimekizumab-bkzx) for the treatment of moderate-to-severe hidradenitis suppurativa (HS) in adult patients. Developed by UCB, Bimzelx is the first therapy to target both interleukin-17A (IL-17A) and interleukin-17F (IL-17F). HS is a chronic, painful, inflammatory skin disease affecting approximately one in 100 people.

Clinical Efficacy in Hidradenitis Suppurativa

According to Dr. Alexa B. Kimball, lead author of the studies supporting the approval and a professor of dermatology at Harvard Medical School, the approval addresses a significant unmet need. Phase 3 clinical studies demonstrated that patients treated with bimekizumab-bkzx achieved deep and sustained clinical responses up to 48 weeks.

Brindley Brooks, founder and executive director of HS Connect, US, emphasized the importance of this approval for the HS community, offering a new treatment possibility for those living with moderate-to-severe disease.

UCB's Perspective

UCB executive vice president, head of patient impact, and chief commercial officer Emmanual Caeymaex stated the company's excitement about the approval, marking the fifth patient population that may benefit from Bimzelx in the U.S. He highlighted UCB's commitment to addressing unmet needs in immune-mediated inflammatory diseases.

Sustained Efficacy in Other Inflammatory Conditions

Data presented by UCB at ACR Convergence 2024 showcased Bimzelx's sustained clinical improvements and patient-reported outcomes in conditions such as psoriatic arthritis (PsA) and axial spondyloarthritis (AS). Dr. Fabian Proft from Charité Universitätsmedizin in Berlin, Germany, noted that existing treatments may lose efficacy over time, making the sustained efficacy of bimekizumab-bkzx over two years particularly valuable.

The data revealed high levels of response, offering insights into bimekizumab-bkzx’s sustained efficacy in non-radiographic axial spondyloarthritis, ankylosing spondylitis, and psoriatic arthritis. These results reinforce the potential of bimekizumab-bkzx as an effective approach to targeting key inflammatory pathways involved in PsA, nr-axSpA, and AS through dual inhibition of IL-17A and IL-17F.