FDA Approves HS Treatment Bimzelx

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FDA approved Bimzelx for the treatment of adults with moderate-to-severe hidradenitis suppurativa (HS), a painful inflammatory skin disease.¹ The medication, developed by UCB, is the first of its kind to be approved. It’s unique approach to treating HS is by selectively inhibiting IL-17F along with IL-17A.

HS is considered a debilitating disease and the symptoms can cause significant pain and disruption to patients’ lives.

Alexa B. Kimball, MD, MPH, is deaconess at Beth Israel Medical Center and a professor of dermatology at Harvard Medical School in Boston, Massachusetts. As the lead author of the studies used to approve the drug, she said, “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.”

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

In the same press release, UCB executive vice president, head of patient impact, and chief commercial officer Emmanual Caeymaex said, “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.”

UCB presented data on Bimzelx at ACR Convergence 2024 which showed sustained clinical improvements and patient-reported outcomes in various conditions, including PsA an AS.²

In a press release, said Dr Fabian Proft, Department of Gastroenterology, Infectiology and Rheumatology at Charité Universitätsmedizin in Berlin, Germany, said, “A major challenge for practicing rheumatologists is that existing treatments may lose efficacy over time, leaving patients vulnerable to debilitating symptoms. The new results presented at ACR Convergence 2024 show that bimekizumab-bkzx met stringent clinical endpoints, with high levels of efficacy across multiple domains of axial spondyloarthritis and psoriatic arthritis, and were sustained for two years, demonstrating bimekizumab-bkzx’s ability to remain effective over the long term.”

In the same press release, UCB’s head of patient evidence, said, “These new two-year data, revealing high levels of response, offer exciting insights into bimekizumab-bkzx’s sustained efficacy in non-radiographic axial spondyloarthritis, ankylosing spondylitis, and psoriatic arthritis. The 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, reflecting our ambition to provide differentiated treatments for people living with chronic inflammatory diseases.”

Sources

1. UCB Receives U.S. FDA Approval for BIMZELX® (bimekizumab-bkzx) as the First IL-17A and IL-17F Inhibitor for Adults with Moderate-to-Severe Hidradenitis Suppurativa. UCB. 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. New BIMZELX® (bimekizumab-bkzx) Data at ACR Convergence 2024 Highlights UCB’s Efforts to Deliver Differentiated Care for Patients with Psoriatic Arthritis and Axial Spondyloarthritis. UCB. November 14, 2024. Accessed November 20, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/new-bimzelxr-bimekizumab-bkzx-data-at-acr-convergence-2024-highlights-ucbs-efforts-to-deliver-differentiated-care-for-patients-with-psoriatic-arthritis-and-axial-spondyloarthritis