The FDA approved Bimzelx (bimekizumab-bkzx), a biologic designed to target both interleukin-17A and interleukin-17F for moderate-to-severe hidradenitis suppurativa in adults.
Approval was based on data from the BE HEARD I and BE HEARD II Phase 3 trials, which assessed the effectiveness and safety of Bimzelx in 1,014 participants with moderate-to-severe hidradenitis suppurativa (HS).
At week 16, a higher proportion of patients treated with Bimzelx achieved a 50% or greater reduction in abscess and inflammatory nodule count (HiSCR50) compared with placebo, with no increase in abscesses or draining tunnels. Clinical responses, including achieving HiSCR75, were maintained through Week 48. The safety profile aligned with data from other indications, with no new safety concerns identified.
Common adverse reactions were reported in at least 1% of patients with plaque psoriasis and HS including upper respiratory tract infections, oral candidiasis, headaches, injection site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other Candida infections, and fatigue.
Bimzelx is associated with potential risks, including suicidal ideation and behavior (SI/B), serious infections, and inflammatory bowel disease (IBD). Physicians should carefully assess the risks and benefits before prescribing, particularly for patients with a history of SI/B, recurrent infections, or active IBD, and monitor patients for mood changes, signs of infection, and IBD symptoms.
Patients should undergo tuberculosis (TB) screening before treatment, with Bimzelx contraindicated in active TB, and latent TB requiring prior treatment. Liver function should be evaluated at baseline and monitored during therapy, with treatment discontinued if liver injury is identified. Vaccinations should be up to date before initiating Bimzelx, and live vaccines should be avoided during its use.
Bimzelx is also approved for four other indications in the U.S., including plaque psoriasis, psoriatic arthritis, non-radiographic axial spondylarthritis, and ankylosing spondylitis.
