News
FDA has set a PDUFA date for review of bimekizumab to treat psoriasis on 15 October 2021.- UCB
UCB announced that the FDA has set the 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 at October 15, 2021.
Bimekizumab for the treatment of adults with moderate to severe plaque psoriasis is currently under review by the FDA for the BLA and the European Medicines Agency (EMA) for the Marketing Authorization Application (MAA), respectively. Regulatory reviews are also underway in Japan, Australia and Canada.
Condition: Psoriasis
Type: drug
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
4 mins