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# UCB Faces Another Review Delay on Bimekizumab
- URL: https://www.fdaweb.com/ucb-faces-another-review-delay-on-bimekizumab/
- Published: 2023-09-20T12:00:00.000Z
- Updated: 2026-09-14T18:57:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155378

UCB says its BLA for bimekizumab, indicated for treating adults with moderate to severe plaque psoriasis, is facing another FDA review extension. While the company says FDA is continuing its review following an April pre-licensure inspection at its Belgium manufacturing facility, the agency has not yet communicated the timelines required to take final action on the application. “At this time, UCB no longer anticipates FDA action in the third quarter,” it says.

In late June, UCB said FDA’s BLA review had been extended for undisclosed reasons. UCB previously said it expected FDA action in the second quarter and that was then pushed back into the third quarter.

 In 5/2022, FDA issued UCB a complete response letter on the original BLA, indicating that preapproval inspection observations must be resolved before the submission could be approved. UCB now says it has received the Establishment Inspection Report from FDA regarding the latest inspection, noting that the agency has concluded that this inspection is successfully closed. 

UCBIt describes bimekizumab as a humanized monoclonal antibody that is designed to selectively inhibit both interleukin 17A and interleukin 17F, two key cytokines that affect inflammatory processes.