Bimekizumab

FDA approves Bimzelx for hidradenitis suppurativa (HS), a chronic skin inflammation affecting 1 in 100 people. Bimzelx, a monoclonal antibody, is the first treatment blocking both interleukin 17F and 17A, key proteins causing HS inflammation. Tested in two studies with 1,014 patients, Bimzelx showed significant improvement by week 16, with symptom relief lasting up to 48 weeks. Side effects include upper airway infections, injection site reactions, and others. Patients should discuss medical history with their doctor before use.

FDA approves Bimzelx, developed by UCB, for moderate-to-severe hidradenitis suppurativa (HS), targeting IL-17F and IL-17A. Clinical studies showed deep and sustained responses up to 48 weeks, addressing significant unmet needs. Bimzelx is now available for HS patients in the U.S., marking a significant step in treating chronic inflammatory diseases.

The hidradenitis suppurativa market is projected to grow at a CAGR of 12.4% by 2034, driven by increased awareness, treatment access, biologic therapy approvals, and a robust pipeline. The market size in the 7MM was USD 1.4 billion in 2023, with approximately 6.2 million prevalent cases. Key companies and treatments include Incyte Corporation, AbbVie, MoonLake Immunotherapeutics, and therapies like Povorcitinib, RINVOQ, Lutikizumab, and Sonelokimab. Regulatory milestones and clinical trials are advancing, with potential market shifts expected from emerging therapies.

FDA approves Bimzelx, the first interleukin-17F and -17A inhibitor, for moderate to severe hidradenitis suppurativa in adults, based on BE HEARD trials results.

UCB's Bimzelx (bimekizumab-bkzx) approved by FDA for moderate-to-severe hidradenitis suppurativa (HS), a chronic inflammatory skin disease affecting 1% of the US population, more common in women. Bimzelx, also approved for other autoimmune conditions, selectively binds to inflammatory cytokines, reducing HS symptoms by 50% within 16 weeks in phase 3 studies. Administered subcutaneously, it offers a new treatment option with common side effects including upper respiratory tract infections, oral candidiasis, and headache. List price is $7,552.80 per 1 mL, but insurance coverage can reduce costs significantly.

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FDA approves UCB’s BIMZELX for moderate-to-severe hidradenitis suppurativa, targeting IL-17F and IL-17A, addressing unmet needs with deep and sustained clinical responses.

UCB announced FDA approval of BIMZELX for moderate-to-severe hidradenitis suppurativa, supported by Phase 3 studies BE HEARD I and II. This marks the fifth U.S. indication for BIMZELX, initially approved in October 2023 for moderate-to-severe plaque psoriasis.

UCB’s Bimzelx approved by FDA for active moderate-to-severe hidradenitis suppurativa in adults, supported by BE HEARD I and II studies showing significant improvement in HS signs and symptoms.

FDA approves BIMZELX® (bimekizumab-bkzx) for moderate-to-severe hidradenitis suppurativa, supported by Phase 3 studies BE HEARD I and II showing improved signs and symptoms at Week 16, sustained to Week 48.