The FDA has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics License Application (BLA) of Ocrevus (ocrelizumab) to treat Multiple Sclerosis to 28 March 2017.- Genetech + Roche

Genentech, a member of the Roche Group announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics License Application (BLA) of Ocrevus (ocrelizumab) to March 28, 2017. The extension is the result of the submission of additional data by Genentech regarding the commercial manufacturing process of Ocrevus, which required additional time for FDA review. The extension is not related to the efficacy or safety of Ocrevus.