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.”
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