FDA Approves Ocrevus for Primary Progressive MS

The FDA recently approved Ocrevus (ocrelizumab; Roche) for both relapsing and primary progressive forms of multiple sclerosis (MS). Ocrevus is the first disease-modifying therapy approved to treat primary progressive MS, one of the most disabling forms of the condition. 

“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, chief medical officer at Roche. “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.” 

In a pair of phase 3 studies involving patients with relapsing forms of MS, Ocrevus showed superior efficacy by reducing relapses per year by almost half, slowing the worsening of disability, and significantly reducing MRI lesions compared with Rebif (high-dose interferon beta-1a; EMD Serono) over a 2-year controlled treatment period. Serious adverse events and serious infections affected a similar proportion of patients taking Ocrevus compared with Rebif. 

In another phase 3 study involving patients with primary progressive MS, Ocrevus was the only treatment to significantly slow disability progression and reduce MRI lesions compared with placebo over a 3-year follow-up period. The proportion of patients experiencing serious adverse events and adverse events was similar for Ocrevus and placebo.

The most common side effects associated with Ocrevus were infusion reactions and upper respiratory tract infections, which were mainly mild to moderate in severity.

Ocrevus is administered every 6 months by intravenous infusion. The first dose is given as two 300 mg infusions 2 weeks apart. Subsequent doses are provided as single 600 mg infusions.

 “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, CEO of the Consortium for MS Centers. “For many people living with MS, this FDA approval is a source of hope.”—Jolynn Tumolo