29 msfocusmagazine.org FDA Approves Ocrelizumab The next huge milestone for the MS community has finally been reached. In late March, the Food and Drug Administration approved Ocrevus (ocrelizumab), to treat adult patients with relapsing MS, but also those living with primary progressive MS. Ocrevus produced by Genentech, is the first drug approved by the FDA for the treatment of PPMS. Ocrevus is an intravenous infusion treatment given every six months. Doctors are now able to prescribe the drug and it is available in clinics. There is no washout period. Sandra Horning, M.D., chief medical officer and head of Global Product Development at Genentech, said, “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.” The New England Journal of Medicine recently published the results from three Phase 3 trials of Ocrevus, and the results speak for themselves. As an RMS treatment, Ocrevus went through two large clinical trials (OPERA I and OPERA II), featuring 1,656 participants who were treated for 96 weeks. These studies directly compared Ocrevus to another MS treatment, Rebif (interferon beta-1a). In both trials, the patients receiving Ocrevus had reduced relapse rates and reduced worsening of disability compared to Rebif. The third study, lasting 120 weeks and featuring 732 MS patients with PPMS, compared Ocrevus to a placebo. The study regularly tested the volume of brain lesions, as well as the participants’ ability to walk 25 feet. Ocrevus proved effective at slowing disease progression, lowering the risk of progression by up to 25 percent compared to the progression in the placebo group. Like all MS treatments, Ocrevus does have the potential for side effects. Discuss the possible benefits and risks with your health- care team. With the FDA’s approval, Ocrevus joins over a dozen other MS treatments, but now shines a hopeful light on those with PPMS. For people who qualify, Genentech plans to offer patient assistance programs through Genentech Access Solutions. More information is also available at 866-4ACCESS (866-422-2377) or www.Genentech-Access.com. Medicine & Research