CHMP recommends EU approval of... Note

CHMP recommends EU approval of Roche’s Ocrevus for children and adolescents with relapsing multiple sclerosis

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended Ocrevus for treating pediatric patients aged 10 and older with relapsing forms of multiple sclerosis (RMS). This follows the U.S. FDA's approval in May 2026. Ocrevus is the first high-efficacy anti-CD20 treatment option for young MS patients. The positive opinion addresses a critical need for children and adolescents who experience more frequent and severe relapses than adults. The recommendation is based on the Phase III OPERETTA 2 study. This study demonstrated Ocrevus's non-inferiority to fingolimod in relapse control. It also showed superiority in suppressing brain lesions. Ocrevus reduced the risk of relapses by 48% and significantly decreased new or enlarging T2 lesions (-48%) and gadolinium-enhancing active T1 lesions (-87%). The safety profile in children and adolescents was consistent with that observed in over 525,000 adult patients globally. Early high-efficacy treatment is crucial given that at least 40,000 children and adolescents worldwide live with MS. Ocrevus targets CD20-positive B cells, implicated in myelin and axonal damage in MS. Roche continues its commitment to developing treatments for neurological conditions, including MS.