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UCB : FDA Defers Action On BLA For Bimekizumab Due To Travel Restrictions

UCB said that the U.S. Food and Drug Administration has informed the company that it was unable to complete review of the Biologics License Application or BLA for bimekizumab for the treatment of moderate to severe plaque psoriasis by the Prescription Drug User Fee Action (PDUFA) date of October 15, 2021.

The FDA cited only the inability to conduct on-site facility inspections due to travel restrictions as the reason for deferral, the company said in a statement.

The FDA had determined that on-site inspections of the European manufacturing facilities for bimekizumab are required before the FDA can approve the application.

UCB noted that it is committed to bringing bimekizumab to patients with moderate to severe plaque psoriasis in the U.S. as soon as possible and continues to work with the FDA to support the ongoing review.

UCB said its financial guidance for 2021 and 2025 remains unchanged.

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