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UCB’ Bimzelx (bimekizumab) Receives the US FDA’s Approval for the Treatment of Adults with Moderate to Severe Plaque Psoriasis

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UCB’ Bimzelx (bimekizumab) Receives the US FDA’s Approval for the Treatment of Adults with Moderate to Severe Plaque Psoriasis

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  • The approval was based on 3 P-III trials (BE READY, BE VIVID and BE SURE) evaluating bimekizumab in 1480 adults which showed that all studies met their co-1EPs & all ranked 2EPs
  • Patients treated with bimekizumab achieved superior levels of skin clearance at 16wk. vs ustekinumab, PBO & adalimumab as measured by 90% improvement in PASI 90 & an IGA response of clear or almost clear skin (IGA 0/1). The 2EPs incl. PASI 75 at 4wk. & PASI 100 (complete skin clearance) at 16wk.
  • 8 out of 10 patients who received bimekizumab (320mg, q4w) achieved PASI 90 & IGA 0/1 at 16wk. 6 out of 10 patients achieved PASI 100, clinical responses were rapid with more than 7 out of 10 patients achieving PASI 75 at 4wk. following 1 dose (320mg), clinical responses at 16wk. (PASI 90 & 100) were maintained for ~1yr.

Ref: UCB | Image: UCB

Related News:- UCB’s Bimzelx (bimekizumab) Receives EC’s Marketing Authorisation for the Treatment of Psoriatic Arthritis and Axial Spondyloarthritis

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Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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