FDA Approves BIMZELX For Treating Hidradenitis Suppurativa Treatment
FDA approves BIMZELX® for moderate-to-severe hidradenitis suppurativa, offering improved treatment options.
Breaking News
Nov 21, 2024
Simantini Singh Deo
.png)
UCB, a global biopharmaceutical company, has 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). BIMZELX is the first and only medication designed to selectively inhibit interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key contributors to the inflammatory process in HS.
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, mentioned, “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.”
Hidradenitis suppurativa is a chronic, painful, and recurring skin condition characterised by the development of nodules, abscesses, and pus-filled fistulas, often in areas like the armpits, groin, and buttocks. The condition can lead to frequent flare-ups, causing significant pain and impacting a person’s quality of life.
Brindley Brooks, Founder and Executive Director of HS Connect, U.S., said in a statement, “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 treating people in the U.S. living with moderate-to-severe disease.”
The FDA's approval is based on data submitted from two Phase 3 trials, BE HEARD I and BE HEARD II, which tested the efficacy and safety of BIMZELX in treating adults with moderate-to-severe HS. The results demonstrated that a higher percentage of patients receiving BIMZELX experienced a 50% or more remarkable improvement in HS symptoms after 16 weeks, compared to those on placebo. Additionally, clinically meaningful improvements were seen in another key endpoint, HiSCR75, at Week 16. These benefits were maintained up to Week 48. The safety profile of BIMZELX was consistent with data from previous trials, and no new safety concerns were identified. The full results of these studies have been published in The Lancet.
Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact and Chief Commercial Officer, UCB, also stated, “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 fifth patient population 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.”
This approval for HS treatment follows BIMZELX’s earlier approvals for treating adults with active psoriatic arthritis, active non-radiographic axial spondyloarthritis with signs of inflammation, and active ankylosing spondylitis. The FDA initially approved BIMZELX in October 2023 to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.