FDA approves ocrelizumab for pediatric relapsing-remitting multiple sclerosis

The FDA has approved intravenous ocrelizumab (Ocrevus; Genentech) for the treatment of relapsing-remitting multiple sclerosis (RRMS) in pediatric patients 10 years and older who weigh at least 55 pounds (25 kg), according to a company announcement.¹

The approval was based on findings from the phase 3 OPERETTA II study, in which ocrelizumab demonstrated noninferiority to fingolimod in reducing annualized relapse rate (ARR) among pediatric patients with RRMS. Investigators also reported superior reductions in MRI lesion activity compared with fingolimod, including a 48% reduction in new or enlarging T2 lesions and an 87% reduction in gadolinium-enhancing T2 lesions.²

According to the release, the safety profile observed in pediatric patients was consistent with previous findings in adults. Serious adverse events and serious infections were reported infrequently and were balanced between treatment groups. No adverse events led to treatment withdrawal in the ocrelizumab group, while 3 patients discontinued fingolimod treatment.

What did Genentech say about the FDA approval of ocrelizumab in pediatric MS?

“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,” Levi Garraway, MD, PhD, chief medical officer and head of global product development for Roche/Genentech, said in the announcement. “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.”

Pediatric-onset multiple sclerosis remains uncommon but clinically significant. Genentech estimated that approximately 5,000 to 10,000 children and adolescents in the United States have pediatric-onset MS.

The company also highlighted the potential impact of earlier access to high-efficacy therapy for younger patients living with the disease.

“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, who was diagnosed with MS at aged 15 years. “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.”

What safety information should physicians know about ocrelizumab?

Ocrelizumab is now approved for relapsing forms of MS in adults, primary progressive MS in adults, and RRMS in pediatric patients 10 years and older who meet the weight requirement.

The prescribing information includes several warnings and precautions. Ocrelizumab can cause infusion reactions, infections, progressive multifocal leukoencephalopathy, and decreased immunoglobulin levels. Additional risks include malignancies, including breast cancer, colitis, and liver damage. The drug is contraindicated in patients with active hepatitis B virus infection or a history of life-threatening allergic reactions to the therapy.

Multiple sclerosis affects an estimated 2.9 million people worldwide. Approximately 85% of patients are initially diagnosed with RRMS, which is characterized by relapses and progressive disability over time. The company noted that slowing disease progression and reducing relapses remain important unmet needs in MS care.

References

1. Genentech. FDA approves Ocrevus for relapsing-remitting multiple sclerosis in pediatric patients 10 years of age and older. News release. Genentech. May 8, 2026. Accessed May 8, 2026. https://www.gene.com/media/statements/ps_050826

2. Mar S, Valeriani M, Steinborn B, et al. Ocrelizumab dose selection for treatment of pediatric relapsing-remitting multiple sclerosis: results of the OPERETTA I study. J Neurol. 2025;272(2):137. doi:10.1007/s00415-024-12879-z