Genentech, a member of the Roche Group  announced recently that the U.S. Food and Drug Administration (FDA) approved Ocrevus (ocrelizumab) as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis. The majority of people with MS have a relapsing form or primary progressive MS at diagnosis.
“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, M.D., 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 identical RMS Phase III studies (OPERA I and OPERA II), Ocrevus demonstrated superior efficacy on the three major markers of disease activity by reducing relapses per year by nearly half, slowing the worsening of disability and significantly reducing MRI lesions compared with Rebif® (high-dose interferon beta-1a) over the two-year controlled treatment period. A similar proportion of people in the Ocrevus group experienced a low rate of serious adverse events and serious infections compared with people in the high-dose interferon beta-1a group in the RMS studies.
In a separate PPMS Phase III study (ORATORIO), Ocrevus was the first and only treatment to significantly slow disability progression and reduce signs of disease activity in the brain (MRI lesions) compared with placebo with a median follow-up of three years. A similar proportion of people in the Ocrevus group experienced adverse events and a low rate of serious adverse events compared with people in the placebo group in the PPMS study.
The most common side effects associated with Ocrevus in all Phase III studies included infusion reactions and upper respiratory tract infections, which were mostly mild to moderate in severity. Results from these three Phase III studies were recently published in the January 19, 2017 issue of the New England Journal of Medicine (NEJM).
About Ocrevus (ocrelizumab)
Ocrevus is a humanized monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, Ocrevus binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved.
Ocrevus is administered by intravenous infusion every six months. The first dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions.

Source: Genentech