U.S. Food and Drug Administration (FDA) has approved Roche’s subsidiary Genentech’s Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS).
This is the first drug approved by the FDA for PPMS. Ocrevus is an intravenous infusion given by a health care professional, the FDA said. The FDA granted this application breakthrough therapy designation, fast track designation, and priority review.
Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research said that 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.
MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. PPMS is characterized by steadily worsening function from the onset of symptoms, often without early relapses or remissions. The U.S. Centers for Disease Control and Prevention estimates that approximately 15 percent of patients with MS have PPMS.
The efficacy of Ocrevus for the treatment of relapsing forms of MS was shown in two clinical trials in 1,656 participants treated for 96 weeks. Both studies compared Ocrevus to another MS drug, Rebif (interferon beta-1a). In both studies, the patients receiving Ocrevus had reduced relapse rates and reduced worsening of disability compared to Rebif, said the FDA.
“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”, said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We believe OCREVUS, given every six months, has the potential to change the disease course for people with MS”, Horning added.