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# FDA Approves UCB’s Psoriasis Therapy
- URL: https://www.fdaweb.com/fda-approves-ucbs-psoriasis-therapy/
- Published: 2023-10-18T12:00:00.000Z
- Updated: 2026-09-14T14:13:38.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5155593

FDA has approved a UCB BLA for Bimzelx (bimekizumab-bkzx) for treating moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The company says the therapy is designed to selectively inhibit two key cytokines driving inflammatory processes – interleukin 17A and interleukin 17F.

The approval was based on data from three Phase 3 studies (BE READY, BE VIVID, and BE SURE) that evaluated the therapy’s efficacy and safety in 1,480 adults with moderate-to-severe plaque psoriasis, the company says. The data showed that at Week 16, 85-91% of patients treated with Bimzelx achieved clear or almost clear skin, with 59-68% achieving the goal of complete clearance, it adds.