FDA misses approval target dates after plant inspections delayed by COVID travel restrictions

The US Food and Drug Administration has told UCB Pharma that it was unable to complete a review of the company’s Biologics License Application for its psoriasis treatment, bimekizumab, by an October 15 deadline due to COVID-19 travel restrictions making on-site manufacturing facility inspections in Europe impossible.

The agency informed UCB via letter and is deferring action on the application for the drug to treat moderate to severe plaque psoriasis until the inspections can be completed.

Under FDA guidance relating to pre-approval inspections during the COVID-19 pandemic, the FDA may defer action on a pending application when a facility inspection is planned but cannot be completed by the Prescription Drug User Fee Action (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.

Prof. Dr. Iris Loew Friedrich, Chief Medical Officer and Executive Vice President, Development at UCB said the biopharmaceutical firm was currently in contact with the FDA to schedule inspections of its manufacturing facilities as soon as possible.

“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 US with moderate to severe plaque psoriasis as soon as possible.” she said.

Bimekizumab received marketing authorization in the European Union and Great Britain in August. Regulatory reviews are underway in Australia, Canada, Switzerland and Japan.

The day before, Avadel Pharmaceuticals revealed that the FDA had missed its target action date of October 15, having accepted the NDA for the company’s experimental narcolepsy treatment, FT218.

“We have addressed all questions received to date and remain confident that the package we have submitted satisfies all of the FDA’s requests,” said Greg Divis, CEO of Avadel. “We have not been informed of any deficiencies in our application and remain fully committed to work closely with the FDA for the duration of its review of our NDA for FT218.”