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). According to UCB, BIMZELX 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, Massachusetts. “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.
 
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 BIMZELX in the treatment of adults with moderate-to-severe HS.
 
“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,” 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 BIMZELX 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. BIMZELX 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.