The U.S. Food and Drug Administration approved the use of Ocrevus, produced by Genentech, for the treatment of relapsing-remitting multiple sclerosis in pediatric patients 10 years of age and older who weigh 55 pounds or more. It is estimated that approximately 5,000-10,000 children and adolescents have pediatric onset of MS in the United States.

In the OPERETTA II study, Ocrevus demonstrated noninferiority to fingolimod in reducing the annualized relapse rate and superiority in reducing new or enlarging T2 lesions and gadolinium-enhancing T2 lesions. The safety profile in pediatric patients was consistent with that observed in adult patients. Serious adverse events and serious infections were infrequently observed and well balanced. No adverse events led to treatment withdrawal in the Ocrevus group, and three patients withdrew in the fingolimod group.

According to Emily Blosberg, founder of Mr. Oscar Monkey, diagnosed with MS at 15 years old, “Growing up with MS, I know the frustration of being dismissed and the fear of what comes next. Having an FDA-approved, high-efficacy treatment option like Ocrevus available for age-appropriate children and adolescents is a game changer. It means the next generation of patients won't have to wait for answers — they have an opportunity to take control of their disease early and potentially stop relapses and brain lesions before they have a chance to take a toll.”