CHMP Backs Roche's Ocrevus for Children and Teens With Relapsing MS

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โดย Roche·EU·Read original
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The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Roche's Ocrevus, or ocrelizumab, intravenous infusion for patients aged 10 years and older with relapsing forms of multiple sclerosis, making it the first high-efficacy anti-CD20 treatment option for people with MS as young as 10 years old. The positive opinion rests on the Phase III OPERETTA 2 study, in which Ocrevus was non-inferior to fingolimod, the current standard treatment in paediatric MS, at controlling relapses and reduced the risk of relapses by 48% compared with fingolimod. In the same trial Ocrevus was superior at reducing brain inflammation, with significant reductions in new or enlarging T2 lesions of 48% and gadolinium-enhancing active T1 lesions of 87%, and its safety profile in children and teens was consistent with that seen in adults, with no patients stopping treatment due to side effects. The U.S. FDA approved Ocrevus for paediatric RMS patients in May 2026, and a final decision from the European Commission is expected in the near future. At least 40,000 children and adolescents are living with MS worldwide, with roughly one-third in Europe.

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CHMP recommended approval of Roche's Ocrevus for paediatric relapsing MS, expanding the drug's label in Europe.

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