Roche has received a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Ocrevus (ocrelizumab) in children and adolescents with relapsing forms of multiple sclerosis (RMS).
The recommendation covers paediatric patients aged 10 years and older with relapsing MS. A final decision from the European Commission is expected in the coming months.
Ocrevus is already widely used to treat multiple sclerosis in adults. In May 2026, the US Food and Drug Administration (FDA) also approved Ocrevus for paediatric patients with relapsing MS, expanding its use to younger patients.
Roche said the positive CHMP opinion could help address a treatment gap for children and teenagers living with MS. Paediatric MS can lead to frequent relapses and may affect school attendance, daily activities and long-term physical and cognitive health.
The EMA recommendation is based on findings from the Phase III OPERETTA 2 study. The trial evaluated Ocrevus against fingolimod, a commonly used treatment for paediatric multiple sclerosis.
Results showed that Ocrevus was non-inferior to fingolimod in controlling relapses. Roche reported that treatment with Ocrevus reduced the risk of relapse by 48% compared with fingolimod.
Ocrevus also showed stronger results in reducing signs of brain inflammation. The treatment led to a 48% reduction in new or enlarging T2 lesions and an 87% reduction in gadolinium-enhancing active T1 lesions.
The safety profile seen with Ocrevus in children and teenagers was consistent with previous findings in adults, according to Roche. No patients in the OPERETTA 2 study stopped treatment because of side effects.
Roche Chief Medical Officer Levi Garraway said the CHMP recommendation brings the company closer to making a high-efficacy treatment available to younger people with MS in Europe. The company also pointed to more than a decade of experience with Ocrevus in adults.
Multiple sclerosis in children and adolescents is relatively uncommon but can be more active than the disease seen in adults. Roche estimates that at least 40,000 children and adolescents worldwide are living with MS, with around one-third of them in Europe.
The expected European Commission decision will determine whether Ocrevus can be approved for paediatric RMS patients aged 10 years and older across the European Union.