Genentech Announces FDA Approval of OCREVUS, the First and Only Medicine for Both Relapsing and Primary Progressive Forms of Multiple Sclerosis

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today (March 28, 2017) 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 at Genentech. “Until now, no FDA-approved treatment has been available to the primary progressive MS (PPMS) 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 relapsing multiple sclerosis (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.
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