EU regulators recommend Ocrevus for pediatric multiple sclerosis

The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, has recommended the approval of Ocrevus (ocrelizumab) for pediatric patients aged 10 and older with relapsing forms of multiple sclerosis (MS).

The recommendation is based on findings from the phase 3 OPERETTA 2 study, which compared intravenous ocrelizumab to fingolimod. The study demonstrated that ocrelizumab was noninferior in relapse control and provided superior suppression of MRI-detected brain lesions in pediatric patients.

The European Commission is expected to issue a final decision on the medication's approval soon. Roche, the global marketer of Ocrevus, noted that this development aims to address a treatment gap for young people with MS, who often experience more frequent and severe relapses than adults.