The U.S. Food and Drug Administration (FDA) has approved UCB’s BIMZELX (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS). Bimekizumab-bkzx is the first and only approved medicine designed to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A).
“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,” said 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, MA, U.S. “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, recurring, painful and potentially debilitating inflammatory skin disease. The main symptoms are nodules, abscesses and pus-discharging fistulas, i.e., channels leading out of the skin, typically in the armpits, groin and buttocks. People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.
“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,” said Brindley Brooks, Founder and Executive Director, HS Connect, U.S.
The approval is supported by data from two Phase 3 studies, BE HEARD I and BE HEARD II, which evaluated the efficacy and safety of bimekizumab-bkzx in the treatment of adults with moderate to severe HS. Results showed that a higher proportion of patients treated with bimekizumab-bkzx vs. placebo achieved a 50 percent or greater improvement in HS signs and symptoms at Week 16, as measured by HiSCR50, the primary endpoint in both trials. Bimekizumab-bkzx treatment also resulted in clinically meaningful improvements in the key ranked secondary endpoint, HiSCR75, vs. placebo at Week 16. Clinical responses were sustained to Week 48. The safety profile of bimekizumab-bkzx was consistent with safety data seen in previous trials across indications with no new safety signals. Detailed results from BE HEARD I and BE HEARD II have been published in The Lancet.
“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,” said Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact and Chief Commercial Officer, UCB. “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 FDA approval of bimekizumab-bkzx for the treatment of adults with moderate to severe hidradenitis suppurativa follows its recent approvals for the treatment of adults with active psoriatic arthritis, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation and adults with active ankylosing spondylitis. Bimekizumab-bkzx was first approved in the U.S. in October 2023, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
