UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that they were unable to complete review of the Biologics License Application (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 Agency has determined that on-site inspections of the European manufacturing facilities for bimekizumab are required before the FDA can approve the application. The FDA indicated that they were unable to conduct the inspections during the current review cycle due to COVID-19 related restrictions on travel. Therefore, the FDA is deferring action on the application until the inspections can be completed. In the letter, the Agency cited only travel restrictions and its inability to complete facility inspections as the reason for the deferral. The BLA for bimekizumab remains under review.
Under FDA guidance relating to pre-approval inspections during the COVID-19 pandemic, the Agency may defer action on a pending application when a facility inspection is planned but cannot be completed by the PDUFA goal date due to COVID-related travel restrictions, provided that no deficiencies have been identified and the application otherwise satisfies the requirements for approval.
"We are currently in contact with the FDA to schedule the inspections of our manufacturing facilities as soon as possible," said Prof. Dr. Iris Loew Friedrich, Chief Medical Officer and Executive Vice President, Development UCB. "We have provided the Agency with the manufacturing schedules through the first quarter of 2022, and we are eager to assist the FDA to allow its assessment of bimekizumab to be finalized. We are committed to bringing bimekizumab to patients in the U.S. with moderate to severe plaque psoriasis as soon as possible."
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