Roche Ocrevus Gains CHMP Support for Pediatric MS Patients

Basel, Switzerland, September 18, 2026

Roche Ocrevus Moves Toward Pediatric EU Approval

The recommended indication covers children and adolescents aged 10 years and older but younger than 18 years who have relapsing multiple sclerosis. RMS is a form of multiple sclerosis characterized by episodes of new or worsening neurological symptoms, known as relapses, followed by periods of partial or complete recovery. Multiple sclerosis can begin during childhood or adolescence, although pediatric-onset MS represents a smaller proportion of total MS cases. Early disease activity can be associated with significant neurological impact, making access to effective disease-modifying treatments an important area of pediatric neurology.

Ocrevus is a monoclonal antibody targeting CD20-positive B cells, which are involved in immune-system activity associated with multiple sclerosis. By reducing CD20-positive B cells, ocrelizumab is designed to modulate the immune response involved in the disease process. Ocrevus is already authorised in the European Union for certain adult patients with RMS and for adults with early primary progressive multiple sclerosis. The proposed pediatric extension would therefore broaden the medicine’s European indication to include a younger population with relapsing disease. The CHMP opinion is a recommendation rather than a final EU marketing authorisation. The recommendation will now be considered by the European Commission, which is responsible for issuing the legally binding decision on the marketing authorisation.

Phase 3 OperaCT Supports Pediatric Ocrevus Use

The CHMP recommendation is based on data from the Phase 3 OperaCT study, which evaluated the efficacy and safety of ocrelizumab in children and adolescents with RMS. According to Roche, the study met its primary endpoint, demonstrating that treatment with Ocrevus resulted in a significant reduction in the number of new or newly enlarging T2 brain lesions compared with interferon beta-1a. MRI-detected brain lesions are an important measure in multiple sclerosis clinical trials because they can provide evidence of inflammatory disease activity in the central nervous system. Reducing the formation of new lesions is therefore an important measure when evaluating disease-modifying treatments for MS.

The OperaCT study enrolled pediatric participants with relapsing multiple sclerosis and compared Ocrevus with interferon beta-1a, an established disease-modifying treatment for MS. Roche reported that the safety profile observed in the pediatric study was consistent with the established safety profile of Ocrevus in its approved adult indications. The company said the findings support the potential use of Ocrevus as a treatment option for pediatric patients with RMS. However, the CHMP recommendation does not mean that the medicine is automatically approved for pediatric use throughout the European Union. The final regulatory decision remains with the European Commission.

Ocrevus Expands Pediatric Multiple Sclerosis Options

The potential pediatric approval would represent an additional treatment option for young people living with relapsing multiple sclerosis. Pediatric MS can involve frequent disease activity, and children with the condition may experience neurological symptoms while also navigating education, physical development, and other aspects of adolescence. Roche’s Ocrevus is administered through intravenous infusion and works by targeting CD20-positive B cells. The treatment has become an established disease-modifying therapy for multiple sclerosis in adults, with regulatory approvals in multiple markets.

The recommended European expansion follows other regulatory developments involving pediatric ocrelizumab. Roche has been evaluating Ocrevus in children and adolescents as part of its broader effort to generate clinical evidence for younger patients with MS. If confirmed by the European Commission, the new indication would make Ocrevus available to eligible pediatric patients aged 10 to under 18 years with RMS under the terms of the European authorisation. It would also expand the role of targeted B-cell depletion in pediatric multiple sclerosis treatment. For Roche, the CHMP opinion represents another regulatory milestone for Ocrevus and its multiple sclerosis portfolio. For the MS community, the decision process highlights continuing efforts to evaluate established disease-modifying therapies specifically in younger patients. The final European Commission decision will determine whether the recommended indication becomes part of Ocrevus’ EU marketing authorisation. Until then, the positive CHMP opinion remains a regulatory recommendation, rather than a final approval.

Source: Roche press release