Bimekizumab
- Generic Name
- Bimekizumab
- Brand Names
- Bimzelx
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1418205-77-2
- Unique Ingredient Identifier
- 09495UIM6V
- Background
Bimekizumab is a humanized monoclonal antibody directed towards IL-17, which was approved for use in the EU on August 20, 2021, for the treatment of plaque psoriasis. It is the first IL-17 inhibitor to target both IL-17A and IL-17F. It has demonstrated superior efficacy as compared to another IL-17 inhibitor, secukinumab, as well as ustekinumab (an IL-12/23 inhibitor) and adalimumab (a TNF inhibitor) in the treatment of moderate-to-severe psoriasis, likely owing to its dual inhibition of both IL-17A and IL-17F. Bimekizumab was also granted FDA approval on October 18, 2023.
- Indication
Bimekizumab is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
- Associated Conditions
- Severe Plaque psoriasis, Moderate Plaque psoriasis
- Associated Therapies
- -
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Compiles top hidradenitis suppurativa articles from 2024
Healio Dermatology compiles top hidradenitis suppurativa articles of 2024, highlighting new FDA-approved treatments and conference content.
UCB Eyes Two More Approvals After This Year's Success
Korea UCB Pharma secured South Korean approval for Bimzelx (bimekizumab) for plaque psoriasis and Zilbrysq (zilucoplan) for myasthenia gravis in 2023. The company aims to expand its portfolio in 2024 with anticipated approvals for Fintepla (fenfluramine) for Dravet and Lennox-Gastaut syndromes, and Rystiggo (rozanolixizumab) for myasthenia gravis. Bimzelx is poised to compete in Korea's plaque psoriasis market with superior efficacy and safety.
Exclusive interview on 2025 physician fee schedule cuts leads November dermatology news
Healio Dermatology's top story in November focused on the CMS's 2025 physician fee schedule cuts and their impact on patient access, with FDA approvals for Emrosi, Bimzelx, and Microlyte Ag/Lidocaine also making headlines.
Focuses on New Launch and Completes Divestment of Mature Product Business in China
UCB sold its mature neurology and allergy portfolio in China, including Keppra®, Vimpat®, Neupro®, Zyrtec®, Xyzal®, and the Zhuhai manufacturing facility, to CBC Group and Mubadala Investment Company for $680 million. The portfolio will be transferred to NeuroGen Pharma, a new CNS-focused company. UCB also entered a commercialization agreement with Bioray to bring Bimzelx® to Chinese patients, shifting its strategy to focus on novel therapies.
Can UCB's Bimzelx compete with Cosentyx in hidradenitis suppurativa?
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FDA Approves Bimzelx for Hidradenitis Suppurativa
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 HS Treatment Bimzelx
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.
Hidradenitis Suppurativa Market to Showcase Remarkable Growth at a CAGR of 12.4% by 2034
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 for adults with moderate to severe hidradenitis suppurativa
FDA approves Bimzelx, the first interleukin-17F and -17A inhibitor, for moderate to severe hidradenitis suppurativa in adults, based on BE HEARD trials results.
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.
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