Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) accepted for review the company’s Biologics License Application (BLA) for OCREVUS™ (ocrelizumab) 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.
"OCREVUS is the first investigational medicine to significantly reduce disability progression in people with relapsing and primary progressive forms of MS," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "We are pleased by the FDA’s decision to classify their review of the BLA as priority because we believe OCREVUS has the potential to help people living with either of these two forms of MS. We will continue to work closely with the FDA and EMA to bring this investigational medicine to people with MS as quickly as possible."
