European Commission approves Ocrevus for pediatric multiple sclerosis

The European Commission has approved the intravenous infusion ocrelizumab, marketed as Ocrevus, for pediatric patients aged 10 and older suffering from recurrent forms of multiple sclerosis. This decision addresses a long-standing therapeutic gap in Europe for younger patients.

Based on the phase III OPERETTA 2 clinical trial, the treatment demonstrated significant efficacy compared to fingolimod, the current standard of care. Roche reported that Ocrevus reduced the risk of relapses by 48% and showed substantial reductions in brain inflammation, specifically regarding T2 lesions and active T1 lesions.

Medical experts note that children and adolescents often experience more frequent and severe relapses than adults. With approximately one-third of the world's estimated 40,000 pediatric multiple sclerosis patients residing in Europe, the authorization aims to provide early, high-efficacy intervention to preserve physical and cognitive health.