Roche's Ocrevus gets CHMP backing for paediatric MS
Roche has moved closer to a European approval for Ocrevus (ocrelizumab) in children and adolescents after the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the drug for paediatric patients aged 10 and older with relapsing forms of multiple sclerosis. A formal decision from the European Commission, which typically follows CHMP recommendations within two to three months, is expected shortly.
The opinion makes Ocrevus the first high-efficacy anti-CD20 therapy to be reviewed for use in MS patients this young in Europe. The US Food and Drug Administration had already granted paediatric approval for the same indication in May 2026, meaning Roche is tracking closely between the two major regulatory jurisdictions.
Trial data
The CHMP's opinion rests principally on results from the Phase III OPERETTA 2 study, which compared Ocrevus directly against fingolimod, currently the standard of care in paediatric relapsing MS. Ocrevus met the primary endpoint of non-inferiority in relapse control and went further on key MRI measures. New or enlarging T2 brain lesions fell by 48% in the Ocrevus arm relative to fingolimod, while gadolinium-enhancing active T1 lesions were reduced by 87%. No patients in the study discontinued treatment owing to adverse events, and the safety profile was consistent with the established adult dataset, which now spans more than 525,000 patients.
Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development, said the positive opinion brings the company "closer to bridging a longstanding gap in Europe, offering young people with MS a high-efficacy therapy backed by a decade of adult experience."
Brenda Banwell, Chair of Paediatrics at Johns Hopkins Medicine and co-investigator on OPERETTA 2, noted that children with MS face more frequent and severe relapses than adults, alongside disruption to schooling and social development, and risk of long-term disability. She described extending Ocrevus to younger patients as "an important step forward to suppress disease activity early on."
Market and competitive context
At least 40,000 children and adolescents are living with MS worldwide, according to the MS International Federation's Atlas of MS 2026, with roughly one-third in Europe. The condition is rare enough in this age group that treatment guidelines have historically lagged behind adult practice, and disease-modifying options have been limited largely to injectable interferons and fingolimod.
The paediatric MS space attracts increasing attention from neurology-focused developers. Novartis, which markets fingolimod (Gilenya) in the adult and paediatric populations, will find its position as standard of care under direct competitive pressure if the European Commission formalises the CHMP's opinion. Other high-efficacy agents in adult MS, including natalizumab and cladribine, have not yet secured comparable paediatric approvals in Europe, which could give Roche a period of first-mover advantage in the CD20 mechanism class for this age group.
Ocrevus itself is a humanised monoclonal antibody targeting CD20-positive B cells, the same mechanism deployed in the adult formulation. The drug is administered intravenously every six months following an initial two-dose induction. Roche also markets a subcutaneous formulation, Ocrevus Zunovo, in the United States, though the current paediatric development programme centres on the IV route.
For investors, the paediatric approval represents an incremental revenue opportunity rather than a transformational one, given the small patient population. The strategic value lies partly in label breadth and partly in reinforcing Ocrevus's position as the reference high-efficacy MS therapy ahead of future biosimilar entry in the adult indication.