FDA approves Ocrevus (ocrelizumab) IV infusion for relapsing-remitting multiple sclerosis in pediatric patients aged 10 years and older – Genentech

Genentech has received 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.

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

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