UCB's bimekizumab-bkzx, marketed as Bimzelx, has received FDA approval for the treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients. This approval marks a significant advancement in the treatment landscape for HS, a chronic and debilitating inflammatory skin disease affecting approximately one in 100 people.
The approval is based on data from two Phase 3 clinical trials, BE HEARD I and BE HEARD II, which demonstrated the efficacy and safety of bimekizumab in treating HS. Bimekizumab is the first and only approved medicine designed to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A).
Clinical Trial Data
The BE HEARD I and BE HEARD II trials were randomized, double-blind, placebo-controlled studies involving 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 findings from the trials include:
- A significantly higher proportion of patients treated with bimekizumab achieved HiSCR50 at Week 16 compared to placebo.
- Bimekizumab treatment also resulted in clinically meaningful improvements in HiSCR75, a more stringent measure of disease improvement, at Week 16.
- Clinical responses were sustained through Week 48, indicating the durability of the treatment effect.
- The safety profile of bimekizumab was consistent with previous trials, with no new safety signals identified.
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, and painful inflammatory skin condition characterized by nodules, abscesses, and pus-discharging fistulas, typically occurring in areas such as the armpits, groin, and buttocks. The disease can significantly impact a patient's quality of life due to pain, flare-ups, and potential complications.
Bimekizumab: Mechanism of Action and Safety
Bimekizumab 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. The drug carries warnings regarding suicidal ideation and behavior, increased risk of infections (including tuberculosis), liver biochemical abnormalities, and inflammatory bowel disease.
Common adverse reactions (≥ 1%) include upper respiratory tract infections, oral candidiasis, headache, injection site reactions, and tinea infections.
UCB's Commitment
Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact and Chief Commercial Officer at UCB, stated, "We are thrilled that with this milestone BIMZELX is now FDA-approved for the treatment of adults with moderate to severe hidradenitis suppurativa... This progress underscores our commitment to addressing unmet needs in hidradenitis suppurativa and other immunological conditions, delivering innovative medicines and raising standards of care."
