FDA delays approval of bimekizumab for plaque psoriasis
US Food and Drug Administration (FDA) Delays Action on 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 (PDUFA) action date, developed by UCB, was initially set for October 15. However, the FDA said it was unable to complete inspections on time due to travel restrictions linked to the ongoing COVID-19 pandemic.
“We are currently in contact with the FDA to schedule inspections of our manufacturing facilities as soon as possible,” Professor Iris Loew Friedrich, medical director and executive vice president, UCB Development, said in a statement. “We have provided the Agency with manufacturing schedules up to the first quarter of 2022 and we look forward to assisting the FDA in finalizing its evaluation of bimekizumab. We are committed to bringing bimekizumab to patients in the United States with plaque psoriasis as soon as possible. “
The treatment is an experimental humanized monoclonal IgG1 antibody that selectively and directly inhibits both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), which are crucial cytokines that cause 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 candidates for systemic therapy in August .