FDA Misses PDUFA Date for Bimekizumab

The FDA was unable to complete review of UCB’s biologics license application for bimekizumab for the treatment of moderate-to-severe plaque psoriasis by the Prescription Drug User Fee Action (PDUFA) date of Oct. 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.

This was the only reason cited for the delay in approval, according to officials at UCB

Iris Loew Friedrich, M.D, Ph.D.

“We are currently in contact with the FDA to schedule the inspections of our manufacturing facilities as soon as possible,” Iris Loew Friedrich, M.D, Ph.D., chief medical officer and executive vice president, development UCB, said in a statement. “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 United States with moderate to severe plaque psoriasis as soon as possible.”

Under FDA guidance relating to preapproval 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.

Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively and directly inhibits both interleukin 17A and interleukin 17F, two key cytokines driving inflammatory processes. The FDA had accepted UCB's application for bimekizumab in September 2020.

In August 2021, bimekizumab received marketing authorization in countries of the European Union/European Economic Area and Great Britain, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Regulatory reviews are under way in Australia, Canada, Switzerland, and Japan.