The U.S. FDA approved Ocrevus for paediatric RMS patients in May 2026. A final decision from the European Commission is expected in the near future.

"Children and teens living with multiple sclerosis experience more frequent and severe relapses than adults, yet their treatment options have lagged behind," said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. "The positive CHMP opinion brings us closer to bridging a longstanding gap in Europe, offering young people with MS a high-efficacy therapy backed by a decade of adult experience."

"Living with a paediatric MS diagnosis means that children and adolescents must navigate a complex condition with unpredictable relapses that require hospital admission and acute therapies, lead to missed days of school and social activities, and face the potential for future disability," said Dr. Brenda Banwell, MD, Chair of Pediatrics, Johns Hopkins Medicine, Pediatrician-in-Chief and Co-Director, Johns Hopkins Children’s Center. "Extending Ocrevus, a proven treatment for adults, to younger patients is an important step forward to suppress disease activity early on, with the goal of preserving their physical and cognitive health."

The CHMP's positive opinion is based on the Phase III OPERETTA 2 study, which showed that Ocrevus was non-inferior to fingolimod (the current standard treatment in paediatric MS) at controlling relapses, reducing the risk of relapses by 48% compared with fingolimod. In OPERETTA 2, Ocrevus was superior at reducing brain inflammation, showing significant reductions in new or enlarging T2 lesions (-48%) and gadolinium-enhancing active T1 lesions (-87%). Ocrevus demonstrated a consistent safety profile in children and teens similar to that seen in adults, with no patients stopping treatment due to side effects.1

At least 40,000 children and adolescents are living with MS worldwide, with roughly one-third in Europe, emphasising the need for early high-efficacy MS treatment.2