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UCB Frustrated By FDA Failure To Inspect Facility For Psoriasis Drug

Delays Expected Approval Of Bimekizumab

 
• By Kevin Grogan

The Belgian group is the latest to be hit by the FDA's difficulties in address the growing backlog of facility inspections, leaving bimekizumab in limbo in the US, despite having just been approved as Bimzelx in Europe.

travel disrupt
COVID-19 travel restrictions prevented inspection of UCB facility • Source: Alamy

UCB S.A.'s hopes of launching bimekizumab in the US before year-end have been thwarted by COVID-19-related travel restrictions that have prevented an inspection of the site where the closely watched psoriasis drug is manufactured.

The IL-17A and IL-17F inhibitor was approved in the EU and the UK in August, branded as Bimzelx, and UCB was expecting a similar green light in the US. However, as the Prescription Drug User Fee Action (PDUFA) date of 15 October passed, the US Food and Drug Administration informed the Belgian company that it was unable to complete a review of the biologics license application for bimekizumab until on-site inspections of the European manufacturing facilities for the drug were completed

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