Posted by Michael Wonder on 21 Dec 2016
FDA extends review of application for Ocrevus (ocrelizumab)
20 December 2016 - Roche announced today that the U.S. FDA has extended the Prescription Drug User Fee Act date for its review of the biologics licence application of Ocrevus (ocrelizumab) to 28 March 2017.
The extension is the result of the submission of additional data by Roche 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.
