FDA approves Ocrevus (ocrelizumab) to treat relapsing and primary progressive forms of multiple sclerosis.- Genentech + Roche

Genentech, a member of the Roche Group announced that the 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. 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. Ocrevus is given every six months and has the potential to change the disease course for people with MS.

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).

Comment:Primary progressive MS is characterized by steadily worsening function from the onset of symptoms, often without early relapses or remissions. The U.S. Centers for Disease Control and Prevention estimates that approximately 15 percent of patients with MS have primary progressive MS.