EMA panel backs Roche's Ocrevus for paediatric multiple sclerosis

On 18 September 2026, Roche announced that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approving Ocrevus intravenous infusion for paediatric patients aged 10 years and older with relapsing forms of multiple sclerosis. The European Commission is expected to make a final decision in the near future.

The recommendation follows clearance from the U.S. Food and Drug Administration for the same paediatric indication in May 2026. The therapy is already used in more than 525,000 adult patients globally.

The opinion relies on findings from the Phase III OPERETTA 2 trial. In that study, Ocrevus proved non-inferior to fingolimod in relapse control, lowering relapse risk by 48%. The drug also reduced new or enlarging T2 brain lesions by 48% and cut gadolinium-enhancing active T1 lesions by 87% compared with fingolimod, with no participants discontinuing treatment due to adverse events.

Multiple sclerosis affects more than 3 million people worldwide, including at least 40,000 children and adolescents, roughly one-third of whom live in Europe.