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Update: UCB’s Bimzelx Approved By FDA, Offering 8-Week Dosing

ByLisa Luckas

10/14/2024
UCB's Bulle BioreacteurUCB's Bulle BioreacteurUCB's Bulle Bioreacteur
  • UCB  received FDA approval for new single-injection device options of BIMZELX® (bimekizumab-bkzx) in 320 mg doses, expanding administration choices for patients with plaque psoriasis and psoriatic arthritis.

Mon Oct 14 06:00:36 -2024 UTC– UCB, a Blackrock investment, received U.S. FDA approval for 320 mg single-injection devices of BIMZELX® (bimekizumab-bkzx) for moderate-to-severe plaque psoriasis and active psoriatic arthritis with coexistent psoriasis.

This new approval offers a single-injection option every eight weeks, enhancing patient convenience.

Approval is supported by bioequivalence studies and follows prior European Commission approval. BIMZELX is a monoclonal antibody targeting IL-17 cytokines.

Risks of Infections

It carries risks of infections, liver abnormalities, and other adverse effects, requiring careful monitoring and patient evaluation before use.

BIMZELX showed sustained efficacy and safety in treating adults with moderate to severe plaque psoriasis.

Psoriasis is one of the most common inflammatory diseases of the skin. It usually progresses in episodes. Typical signs are red, scaly patches that stand out sharply from the healthy skin and are often very itchy.

New Findings

Earlier this year, th ew findings were highlighted at the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California.

The late-breaking platform presentation at AAD demonstrated that bimekizumab-bkzx rapidly achieved and maintained significant clinical and health-related quality-of-life responses over a four-year span. Notably, 60% of patients achieved complete skin clearance (PASI100) by the fourth year.

Responder analyses further indicated that about 90% of patients who reached PASI90 at Week 16, and over 70% who attained PASI100, successfully maintained their responses up to the fourth year.

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Presentation of the study results.
The CHMP opinion on the drug.
FDA considerations preceded.

ByLisa Luckas

Lisa Luckas is a Sr. Business News Editor at Nobot.News.

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