FDA Grants Priority Review to Multiple Sclerosis Drug

The FDA granted review for Genentech’s Biologics License Application for Ocrevus (ocrelizumab) for relapsing and primary progressive multiple sclerosis (MS). The FDA also granted the drug Priority Review Designation.

The European Medicines Agency has also validated the drug’s Marketing Authorization Application. According to a press release from Genentech, if Ocrevus is approved, it can treat approximately 95% of patients with MS.

The phase 3 studies OPERA 1 and OPERA 2 included 1656 patients with relapsing MS, and studied the efficacy and safety of Ocrevus compared with interferon beta-1a treatment.

ORATORIO, another phase 3 study, included 732 patients with primary progressive MS and compared Ocrevus with placebo.

"OCREVUS is the first investigational medicine to significantly reduce disability progression in people with relapsing and primary progressive forms of MS," concluded Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech. "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."