Roche’s Multiple Sclerosis Drug is First Disease-Modifying Therapy Approved by FDA

The US Food and Drug Administration (FDA) has approved Roche’s Ocrevus (ocrelizumab) for the treatment of both relapsing and primary progressive multiple sclerosis (PPMS). The drug is the first disease-modifying therapy for patients with PPMS.

PPMS is one of the most disabling forms of multiple sclerosis (MS), and is marked by steady disease progression without periods of remission. According to Roche, most individuals diagnosed with MS initially suffer from the relapsing form or primary progressive MS.

“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 Dr. Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development. “Until now, no FDA-approved treatment has been available to the primary progressive MS community, and some people with relapsing forms of MS continue to experience disease activity and disability progression despite available therapies. We believe Ocrevus, given every six months, has the potential to change the disease course for people with MS, and we are committed to helping those who can benefit gain access to our medicine.”

In two Phase III clinical trials – named OPERA I and OPERA II – the efficacy of Ocrevus was assessed in 1,656 individuals with relapsing MS. When compared to EMD Serono’s Rebif (high-dose interferon beta-1a), the current standard treatment for MS, Ocrevus performed better on three primary markers of disease activity.

Patients taking Ocrevus experienced nearly 50 percent less relapses per year, and the progressive worsening of disability was slowed. In addition, Ocrevus was associated with a reduction in MRI lesions, compared to Rebif.

“Multiple sclerosis can have a profound impact on a person’s life,” said Dr. Billy Dunn, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “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.”

Approximately 2.3 million people around the world are affected by MS, with an estimated 15 percent of these patients initially diagnosed with PPMS. The approval application for Ocrevus is currently under review by the European Medicines Agency (EMA).

“This is an exciting day for everyone touched by MS, a disease that strikes in the prime of a person’s life when she or he may be starting a career or family,” said June Halper, MSN, APN-C, MSCN, FAAN, Chief Executive Officer at the Consortium for MS Centers. “We have eagerly awaited the FDA approval of Ocrevus because it not only offers a new, highly efficacious treatment option for people with relapsing multiple sclerosis, but it is also the first disease-modifying therapy indicated for primary progressive multiple sclerosis, a highly disabling type of this chronic disease. For many people living with MS, this FDA approval is a source of hope.”