Regulatory Affairs

FDA approves Roche’s Ocrevus for relapsing and primary progressive MS

PBR Staff Writer Published 30 March 2017

Roche has secured approval from the US Food and Drug Administration (FDA) for its Ocrevus (ocrelizumab) to treat patients with relapsing and primary progressive forms of multiple sclerosis (MS).

Ocrevus is a humanised monoclonal antibody that can selectively target CD20-positive B cells, a specific type of immune cell tha is expected to cause myelin (nerve cell insulation and support) and axonal (nerve cell) damage.

Based on preclinical studies, Ocrevus is said to bind to CD20 cell surface proteins expressed on certain B cells but not on stem cells or plasma cells, helping to preserve crucial functions of the immune system.

In two identical RMS Phase III studies such as Opera I and Opera II, Ocrevus showed advanced efficacy on the three major markers of disease activity by decreasing relapses per year by nearly half against Rebif (high-dose interferon beta-1a) over the two-year controlled treatment period.

Opera I and Opera II are phase II, randomised, double-blind, double-dummy, global multi-centre studies, which assessed the efficacy and safety of Ocrevus against interferon beta-1a in 1,656 people with relapsing forms of MS.

In a separate PPMS Phase III study called Oratorio, Ocrevus demonstrated that the reduction of disease activity in the brain (MRI lesions) compared with placebo with a median follow-up of three years.

Oratorio is a phase III, randomised, double-blind and global multi-centre study, which evaluated Ocrevus against placebo in 732 people with PPMS.

Roche chief medical officer and global product development head Dr Sandra Horning said: “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.

“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.”

Image: Site Roche Basel. Photo: courtesy of F. Hoffmann-La Roche Ltd.