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), UCB announced. This approval marks Bimzelx as the first and only approved medicine designed to selectively inhibit both interleukin 17F (IL-17F) and interleukin 17A (IL-17A). The approval is based on data from two Phase 3 studies, BE HEARD I and BE HEARD II, where Bimzelx demonstrated significant improvements in the signs and symptoms of HS compared to placebo at Week 16, with responses sustained through Week 48.
Clinical Efficacy
The efficacy of Bimzelx was evaluated in the BE HEARD I and BE HEARD II trials, which enrolled 1,014 participants with moderate-to-severe HS. The primary endpoint in both studies was HiSCR50 at Week 16, defined as at least a 50% reduction from baseline in total abscess and inflammatory nodule count, with no increase in abscess or draining tunnel count. Key secondary endpoints included HiSCR75 and HS-specific skin pain response at Week 16. The results, published in The Lancet, showed a significantly higher proportion of patients treated with Bimzelx achieving HiSCR50 compared to placebo. These clinical responses were sustained to Week 48, with the safety profile of Bimzelx remaining consistent with previous trials.
Alexa B. Kimball, MD, MPH, investigator and lead author of the studies, noted, "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."
About Hidradenitis Suppurativa
Hidradenitis suppurativa is a chronic, recurring, painful, and potentially debilitating inflammatory skin disease affecting approximately one percent of the population in most studied countries. The condition is characterized by nodules, abscesses, and pus-discharging fistulas typically occurring in the armpits, groin, and buttocks. Patients with HS experience flare-ups and severe pain, significantly impacting their quality of life.
Mechanism of Action
Bimzelx is a humanized IgG1 monoclonal antibody that selectively binds to IL-17A, IL-17F, and IL-17AF cytokines, blocking their interaction with the IL-17RA/IL-17RC receptor complex. This mechanism helps to reduce inflammation associated with hidradenitis suppurativa.
Safety Profile
The most common adverse reactions (≥ 1%) in patients treated with Bimzelx for hidradenitis suppurativa include upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex infections, acne, folliculitis, other candida infections, and fatigue.
The prescribing information for Bimzelx includes warnings regarding suicidal ideation and behavior, the risk of infections (including tuberculosis), liver biochemical abnormalities, inflammatory bowel disease, and the need to avoid live vaccines during treatment.
Other Indications
This FDA approval marks the fifth indication for Bimzelx in the U.S. It is also approved for the treatment of moderate-to-severe plaque psoriasis, active psoriatic arthritis, active non-radiographic axial spondyloarthritis with objective signs of inflammation, and active ankylosing spondylitis.
