FDA Delays Approval of Bimekizumab for Plaque Psoriasis

The US Food and Drug Administration (FDA) is delaying action on a Biologics License Application (BLA) for bimekizumab, a potential treatment for patients with moderate to severe plaque psoriasis, due to problems with on-site inspections of European manufacturing facilities.

The Prescription Drug User Fee Action (PDUFA) date for the drug, developed by UCB, was originally set for October 15. However, the FDA said they were unable conduct inspections in time due to travel restrictions related to the ongoing COVID-19 pandemic.

"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., 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 U.S. with moderate to severe plaque psoriasis as soon as possible."

The treatment is an investigational humanized monoclonal IgG1 antibody that selectively and directly inhibits both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), which are crucial cytokines driving inflammatory processes.

Bimekizumab received marketing authorization from the European Union/ European Economic Area and Great Britain for the treatment of moderate to severe plaque psoriasis in adults with are candidates for systemic therapy in August.