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The Food and Drug Administration (FDA) has accepted the resubmitted Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis.
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively inhibits both interleukin (IL)-17A and IL-17F. UCB, the drug manufacturer, originally submitted the BLA in September 2020, which included 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.
Results from these studies 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.
The FDA subsequently issued a Complete Response Letter in May 2022 noting that certain inspection observations needed 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 Agency has designated the resubmission as ‘Class 2’ with a 6-month review period, and an action date is expected in the second quarter of 2023.
“We will continue to work with the FDA through the review process with the goal of bringing bimekizumab to the dermatology community in the US as soon as possible,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of US, UCB.
Reference
UCB announces FDA acceptance of BLA resubmission for bimekizumab. News release. UCB. December 23, 2022. Accessed December 27, 2022. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-announces-fda-acceptance-of-bla-resubmission-for-bimekizumab.
