FDA Approves Ocrevus for Pediatric Relapsing-Remitting MS

The Food and Drug Administration (FDA) has approved Ocrevus (ocrelizumab; Genentech, South San Francisco, CA) intravenous infusion for the treatment of relapsing-remitting multiple sclerosis (RRMS) in pediatric patients aged 10 years and older with a body weight of ≥25 kg. The new approval was based on findings showing that Ocrevus treatment for children and adolescents with RRMS was noninferior to fingolimod, which was previously the only FDA-approved therapy for patients in this age group with RRMS.

The approval was supported by findings from the OPERETTA II study (NCT05123703), which evaluated Ocrevus in pediatric patients with RRMS. According to a statement released by Genentech, Ocrevus demonstrated noninferiority to fingolimod in reducing annualized relapse rate (ARR). Additionally, Ocrevus demonstrated superiority on MRI-based measures of inflammatory disease activity.

Key Findings

• Ocrevus was noninferior to fingolimod in reducing ARR.
• Ocrevus reduced new or enlarging T2 lesions by 48% compared with fingolimod.
• Gadolinium-enhancing T2 lesions were reduced by 87% compared with fingolimod.
• Serious adverse events and serious infections were infrequent and balanced between groups.
• No adverse events led to treatment withdrawal in the Ocrevus group, compared with 3 withdrawals in the fingolimod group.

Ocrevus is now approved for relapsing forms of MS in adults, primary progressive MS in adults, and RRMS in pediatric patients aged 10 years and older who meet the weight threshold. The therapy is not known to be safe or effective in children younger than 10 years of age or weighing less than 25 kg.

Source

Genentech. FDA approves Ocrevus for relapsing-remitting multiple sclerosis in pediatric patients 10 years of age and older. Published May 8, 2026. Accessed May 11, 2026. https://www.gene.com/media/statements/ps_050826