FDA
FDA approves Ocrevus for pediatric relapsing-remitting MS
Pediatric-onset multiple sclerosis (MS) remains an area of significant unmet need, with limited FDA-approved treatment options despite the importance of early disease control. Ocrevus (ocrelizumab) is already widely used in adult MS and remains the only FDA-approved therapy for primary progressive multiple sclerosis, highlighting its established role as a high-efficacy disease-modifying therapy in MS.
On May 8, 2026, FDA approved Ocrevus for relapsing-remitting multiple sclerosis in pediatric patients aged 10 years and older weighing at least 25 kg, bringing a high-efficacy anti-CD20 therapy to a population with limited approved treatment options. The decision may support earlier use of highly effective disease-modifying therapy in pediatric MS, where preventing relapses and limiting lesion burden are considered critical to long-term neurologic outcomes.
The approval was based on results from the OPERETTA II study, in which intravenous Ocrevus demonstrated noninferiority to fingolimod in reducing annualized relapse rate in pediatric relapsing-remitting MS. Ocrevus also showed superiority for MRI disease activity, reducing new or enlarging T2 lesions by 48% and gadolinium-enhancing T1 lesions by 87% compared with fingolimod.
The findings may be clinically important because many patients with MS continue to receive lower-efficacy oral therapies despite ongoing risk of relapse and progression. Slowing or preventing disability progression while simultaneously controlling relapses remains a major therapeutic goal in MS care.
Safety findings in pediatric patients were generally consistent with the known adult safety profile of ocrelizumab. Serious adverse events and serious infections were uncommon and balanced between treatment groups. No adverse events led to treatment withdrawal in the Ocrevus group, compared with three discontinuations in the fingolimod group.
Clinicians should continue monitoring for infusion reactions, infections, hepatitis B reactivation, progressive multifocal leukoencephalopathy, hypogammaglobulinemia, malignancy risk, colitis, and liver injury, all of which remain important labeled safety considerations with ocrelizumab therapy.
“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.”
Source: Genentech. (2026, May 8). Press release. FDA approves Ocrevus for relapsing-remitting multiple sclerosis in pediatric patients 10 years of age and older