The approval indicates ocrelizumab for RRMS in patients older than 10 years who weigh 55 pounds or more and is supported by data from the OPERETTA II study.
The US Food and Drug Administration (FDA) has approved Genentech’s ocrelizumab (Ocrevus) 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.1
As described in a May 8, 2026, release from the Company, the decision was supported by data from the OPERETTA II study, in which ocrelizumab demonstrated noninferiority to fingolimod in reducing the annualized relapse rate (ARR) and superiority in reducing new or enlarging T2 lesions and gadolinium-enhancing T2 lesions.1
“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,” Emily Blosberg, founder of Mr. Oscar Monkey, diagnosed with MS at 15 years old, said in a statement.1 “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.”
Ocrelizumab is a humanized anti-CD20 monoclonal antibody that selectively targets CD20-expressing B cells, a population implicated in the inflammatory cascade underlying MS-related demyelination and neurodegeneration. The drug received initial FDA approval in 2017 for relapsing forms of MS and primary progressive MS in adults, becoming the first approved therapy for PPMS. The pediatric program builds on more than a decade of clinical experience and data from over 400,000 adult patients treated in both clinical trial and real-world settings.1,2
OPERETTA II is a phase 3, randomized, double-blind, double-dummy, parallel-group, multicenter noninferiority study comparing IV ocrelizumab to oral fingolimod in patients aged 10 to 17 years with pediatric-onset RRMS. Researchers randomly assigned 187 participants in a 1:1 ratio to receive either 600 mg ocrelizumab IV every 24 weeks or daily oral 0.5 mg fingolimod, with matching placebos, during a double-blind period that continued until all patients completed 24 weeks.1,2
The primary objective was to demonstrate noninferiority of ocrelizumab compared to fingolimod in ARR, while secondary objectives included the number of new or enlarging T2 lesions and gadolinium-enhancing (Gd+) T1 lesions at 12 weeks. At baseline, patients had a mean of 57 T2 lesions and 0.5 Gd+ lesions, with nearly half presenting at least 1 enhancing lesion. The median patient age was 15 years, and the cohort was predominantly female at 69%.1
As described in the release from Genentech, in the study, ocrelizumab demonstrated noninferiority to fingolimod, previously the only FDA-approved treatment for RRMS in pediatrics, in reducing the ARR and superiority in reducing new or enlarging T2 lesions (48% reduction vs fingolimod) and gadolinium-enhancing T1 lesions (87% reduction vs fingolimod).1,3
Of note, 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 ocrelizumab group, and three patients withdrew in the fingolimod group.1
"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, MD, PhD, chief medical officer and head of Global Product Development at Genentech.1 "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."
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