Major Breakthrough: FDA APPROVES OCREVUS FOR RELAPSING-REMITTING MULTIPLE SCLEROSIS IN PEDIATRIC PATIENTS 10 YEARS OF AGE AND OLDER

South San Francisco, CA — May 8th, 2026 —

Genentech, a member of the Roche Group has received U.S. Food and Drug Administration (FDA) approval of Ocrevus® (ocrelizumab) intravenous (IV) infusion for the treatment of relapsing-remitting multiple sclerosis (RRMS) in pediatric patients 10 years of age and older who weigh 55 pounds (25 kg) or more. In the OPERETTA II study, Ocrevus demonstrated noninferiority to fingolimod (previously the only FDA-approved treatment for RRMS in pediatrics) in reducing the annualized relapse rate (ARR) and superiority in reducing new or enlarging T2 lesions (48% reduction vs fingolimod) and gadolinium-enhancing T2 lesions (87% reduction vs fingolimod). 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.

“This approval represents a landmark for children living with MS in the U.S. and their families, which can help close the longstanding gap in high-efficacy treatment options for children aged 10 and older,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “By bringing a decade of efficacy and safety data to this younger population, Ocrevus may reduce relapses and potentially redefine what’s possible for their future.”

“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,” said Emily Blosberg, founder of Mr. Oscar Monkey, diagnosed with MS at 15 years old. “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.”

It is estimated that approximately 5,000-10,000 children and adolescents have pediatric onset of MS in the United States [1].

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