The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended EU approval of Roche's Ocrevus (ocrelizumab) for paediatric patients aged 10 years and older with relapsing forms of multiple sclerosis.
Basel-based Roche announced the CHMP opinion on 18 September 2026. The agency will now seek a final decision from the European Commission. In the United States, the FDA approved Ocrevus for paediatric RMS patients in May 2026.
The positive opinion was based on the Phase III OPERETTA 2 study, which found that Ocrevus was non-inferior to fingolimod — the current standard treatment in paediatric MS — at controlling relapses. Ocrevus reduced the risk of relapses by 48% compared with fingolimod. The study also showed superiority in suppressing brain inflammation: new or enlarging T2 lesions fell by 48%, and gadolinium-enhancing active T1 lesions dropped by 87%. No patients discontinued treatment due to side effects, and the safety profile in children aligned with Ocrevus's established record across more than 525,000 adult patients globally.
At least 40,000 children and adolescents live with MS worldwide, roughly one-third of them in Europe, according to the MS International Federation's Atlas of MS 2026.
Levi Garraway, MD, PhD, Roche's chief medical officer and head of global product development, said children and teens with MS experience more frequent and severe relapses than adults, yet treatment options for young patients have lagged behind.
"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," Garraway said.
Dr. Brenda Banwell, chair of paediatrics at Johns Hopkins Medicine, called extending a proven adult therapy to younger patients an important step toward suppressing disease activity early and preserving physical and cognitive health.
Ocrevus is a humanised monoclonal antibody targeting CD20-positive B cells. It is the only therapy approved for both relapsing forms of MS — including relapsing-remitting MS and active secondary progressive MS — and primary progressive MS. The intravenous formulation and the subcutaneous version, marketed as Ocrevus Zunovo in the US, are both administered every six months.
More than 3 million people worldwide live with MS. Approximately 85% are initially diagnosed with relapsing-remitting MS, while about 15% have the primary progressive form. Despite the availability of high-efficacy therapies, over a third of MS patients remain on lower-efficacy treatments.
