UCB: Bimekizumab PDUFA Date Set for October

The FDA's Prescription Drug User Fee Act (PDUFA) date for UCB’s Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis is October 15, 2021, UCB has indicated.

In addition to the FDA BLA under review, bimekizumab is also under review for the treatment of adults with moderate to severe plaque psoriasis by the European Medicines Agency (EMA) for the Marketing Authorization Application (MAA) and by regulators in Japan, Australia, and Canada.

Subject to respective approvals, UCB says it will bring bimekizumab to patients starting in the second half of 2021.