Posted by Michael Wonder on 28 Jun 2016
Roche’s marketing applications for review of Ocrevus (ocrelizumab) in two forms of multiple sclerosis accepted by EMA and FDA
28 June 2016 - Ocrevus is the first investigational medicine seeking marketing authorisation for both relapsing and primary progressive multiple sclerosis.
Roche announced today that the EMA has validated the company’s marketing authorisation application (MAA) of Ocrevus (ocrelizumab) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) in the European Union.
Validation confirms that the submission is complete and signifies the MAA is under review by the EMA’s CHMP. The U.S. FDA has also accepted for review Roche’s biologics license application for Ocrevus for the treatment of RMS and PPMS, and has granted the application priority review designation with a targeted action date of 28 December 2016.
If approved by the EMA and FDA for both indications, Ocrevus would be the first and only treatment for both forms of multiple sclerosis, which affect approximately 95 percent of people at diagnosis.
