Roche’s Ocrevus has moved a step closer to becoming an approved treatment for children and adolescents with relapsing multiple sclerosis in Europe.

 

This, after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended its approval for patients aged 10 and older.

 

The recommendation covers Ocrevus (ocrelizumab) intravenous (IV) infusion for the treatment of paediatric patients with relapsing forms of multiple sclerosis (RMS). A final decision from the European Commission is expected in the near future.

 

The development follows U.S. Food and Drug Administration approval of Ocrevus for paediatric RMS patients in May 2026.

 

“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, 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.”

 

The CHMP recommendation is based on results from the Phase III OPERETTA 2 study, which compared Ocrevus with fingolimod, the current standard treatment for paediatric MS.

 

Ocrevus was found to be non-inferior to fingolimod in controlling relapses and reduced the risk of relapse by 48%. It also demonstrated superior control of brain inflammation, reducing new or enlarging T2 lesions by 48% and gadolinium-enhancing active T1 lesions by 87%.

 

The safety profile in children and adolescents was consistent with that observed in adults, with no patients discontinuing treatment because of side effects.

 

"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, 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."

 

An estimated 40,000 children and adolescents worldwide are living with multiple sclerosis, with roughly one-third in Europe, highlighting the need for effective treatment options that can be used early in the disease.

 

Ocrevus is a humanised monoclonal antibody designed to target CD20-positive B cells, which are thought to contribute to damage to myelin and nerve cells.