Ocrevus (ocrelizumab) filed with FDA and EMA for relapsing multiple sclerosis and primary progressive multiple sclerosis- Genentech/Roche

The FDA has accepted for review the company�s Biologics License Application (BLA) for Ocrevus (ocrelizumab), from Genentech/Roche for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), and granted the application Priority Review Designation with a targeted action date of December 28, 2016. The Ocrevus Marketing Authorization Application (MAA) has also been validated by the European Medicines Agency (EMA). If approved by the FDA and EMA for both indications, Ocrevus would be the first and only treatment indicated for both forms of MS, which affect approximately 95 percent of people at diagnosis.

The Ocrevus marketing applications are based on positive results from three Phase III studies, which met primary and key secondary endpoints. Data from two identical studies (OPERA I and OPERA II) in people with RMS showed superior efficacy of Ocrevus in reducing annualized relapse rates and disability progression sustained for at least three and for at least six months compared with Rebif (interferon beta-1a). Data from the ORATORIO study in people with PPMS showed significant reductions in disability progression sustained for at least three and for at least six months, as well as in as other measures of progressive disease compared with placebo. Overall safety (proportion of patients with adverse events and serious adverse events) of Ocrevus in the Phase III studies was similar to interferon beta-1a in the RMS studies and to placebo in the PPMS study. The most common adverse events associated with Ocrevus were infusion-related reactions and infections, which were mostly mild to moderate in severity.