FDA has approved ocrelizumab (Ocrevus—Genentech) as the first and only drug for both relapsing and primary progressive forms of multiple sclerosis (MS). Two identical RMS Phase III studies found that ocrelizumab demonstrated superior efficacy on the three major markers of disease activity by reducing relapses per year by almost 50%, slowing the worsening of disability, and substantially reducing MRI lesions compared with high-dose interferon beta-1a during the 2-year controlled treatment period. A similar proportion of patients in the ocrelizumab group had a low rate of serious adverse events and serious infections compared with patients in the high-dose interferon beta-1a group in the RMS studies. A separate PPMS Phase III study found that ocrelizumab was the first and only treatment to significantly slow disability progression and decrease signs of disease activity in the brain compared with placebo, with a median followup of 3 years. The most frequently reported adverse effects associated with ocrelizumab in all Phase III studies included infusion reactions and mild-to-moderate upper respiratory tract infections. Sandra Horning, MD, chief medical officer and head of Global Product Development, Genentech, noted that "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." Genentech said ocrelizumab will be available in the United States in 2 weeks.