28 June 2016

Roche has announced that the European Medicines Agency (EMA) has validated the company’s Marketing Authorisation Application (MAA) of OCREVUS® (ocrelizumab) in the European Union (EU) for treating relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). This Validation confirms that the submission is complete and signifies the MAA is under review by the Committee for Medicinal Products for Human Use (CHMP) of EMA. The U.S. Food and Drug Administration (FDA) has also accepted for review the Biologics License Application (BLA) of Roche 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. OCREVUS would be the first and only treatment for both forms of multiple sclerosis (MS) if approved by the EMA and FDA for both indications, which affect approximately 95 percent of people at diagnosis.

“OCREVUS is the first investigational medicine to significantly reduce disability progression in people with relapsing and primary progressive forms of MS. We are pleased by the acceptance of our marketing applications for OCREVUS, which we believe has the potential to help people living with either of these two forms of MS. We will continue to work closely with the EMA and FDA to bring this investigational medicine to people with MS as quickly as possible,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development.

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