The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to UCB regarding the Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis.
According to the CRL, certain inspection observations need to be resolved prior to approval. As part of the review process, the FDA had planned on inspecting the European manufacturing facilities for bimekizumab. The Company is working to address these issues as quickly as possible.
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively inhibits both interleukin (IL)-17A and IL-17F. The application includes data from the phase 3 BE VIVID (ClinicalTrials.gov Identifier: NCT03370133), BE READY (ClinicalTrials.gov Identifier: NCT03410992), and BE SURE (ClinicalTrials.gov Identifier: NCT03412747) studies.
BE VIVID compared bimekizumab to placebo and ustekinumab in 570 patients for 52 weeks; BE READY compared bimekizumab to placebo in 435 patients for 56 weeks; and BE SURE compared bimekizumab to adalimumab in 480 patients for 56 week. Results showed that patients treated with bimekizumab achieved superior skin clearance at week 16 when compared with those who received placebo or adalimumab. Clinical responses were maintained in all studies for up to 1 year.
Update on US FDA review of Biologics License Application (BLA) for bimekizumab. News release. UCB. Accessed May 13, 2022. https://www.ucb.com/stories-media/Press-Releases/article/Update-on-US-FDA-Review-of-Biologics-License-Application-BLA-for-bimekizumab-0