FDA Approves Ocrelizumab (Ocrevus) for Relapsing, Primary Progressive MS

Deborah Brauser


March 29, 2017

The US Food and Drug Administration (FDA) has approved the humanized monoclonal antibody ocrelizumab (Ocrevus, La Roche) for both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) in adults, the agency announced in a statement.

While there was expectation in the field that the drug would be approved for RMS, there was some question about PPMS because no other treatment before has been approved for that indication. 

"Multiple sclerosis can have a profound impact on a person's life," said Billy Dunn, MD, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, in the FDA statement. "This therapy not only provides another treatment option for those with relapsing MS, but for the first time provides an approved therapy for those with primary progressive MS."

Last night's decision from the FDA, released in a late announcement from Genentech, a member of the Roche Group, is based on results from the OPERA 1 and 2 and ORATORIO phase 3 trials. The first two each included about 800 patients with RMS who received intravenous ocrelizumab or the subcutaneous interferon b-1a Rebif (EMD Serono). ORATORIO included 732 patients with PPMS who received the treatment or matching placebo. The main results for all three trials were published earlier this year in the New England Journal of Medicine.

The Prescription Drug User Fee Act date to review the drug was originally scheduled for December 28, but, as reported by Medscape Medical News, the date was extended while the company submitted additional manufacturing process data. The treatment selectively targets CD20-positive B cells.

"The FDA's approval of Ocrevus is the beginning of a new era for the MS community and represents a significant scientific advance with this first-in-class B cell targeted therapy," Sandra Horning, MD, chief medical officer of Genentech, said in a release.

"For many people living with MS, this FDA approval is a source of hope," said June Halper, chief executive officer at the Consortium for MS Centers, in the same release.

At the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2017 last month, ACTRIMS President-Elect Jeffrey A. Cohen, MD, Cleveland Clinic Neurological Institute-Mellen Center, Ohio, told Medscape Medical News that many clinicians in the field would be surprised if the FDA didn't approve the treatment.

"I think it's going to be a very popular medication," Dr Cohen said at the time.

The treatment will be available in the United States within the next 2 weeks, according to the manufacturer. In addition, its Marketing Authorization Application is under review by the European Medicines Agency.

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