EMA Supports Pediatric Expansion of Relapsing MS Therapy

Children aged 10 years or older with relapsing forms of multiple sclerosis (RMS) could soon gain access in Europe to Ocrevus (ocrelizumab, Roche Registration GmbH). The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended extending the drug’s marketing authorization to include pediatric patients aged 10 years or older with RMS with active disease defined by clinical or imaging features.Ocrevus is already approved in the European Union for adults with active relapsing forms of multiple sclerosis and for adult patients with early primary progressive multiple sclerosis.If approved by the European Commission, the decision would expand access in Europe to a high-efficacy anti-CD20 therapy for younger patients with pediatric-onset multiple sclerosis.About Pediatric RMS Multiple sclerosis is a chronic inflammatory demyelinating disease of the central nervous system that can lead to relapses, neurologic deficits, and cumulative disability.In children and adolescents, RMS can present with elevated disease activity, frequent relapses, and a high risk for long-term disability.How the Anti-CD20 Antibody Works Ocrevus's active ingredient, ocrelizumab, is a monoclonal antibody that targets CD20, a protein expressed on the surface of certain B cells. CD20-positive B cells are thought to contribute to the inflammatory processes involved in multiple sclerosis. By depleting CD20-positive B cells, ocrelizumab reduces this inflammatory activity and helps reduce relapses and disease progression. The treatment is administered by intravenous infusion. Pediatric Trial Supports Extension The pediatric extension is supported in part by the phase 3 OPERETTA 2 trial, a randomized, double-blind, multicenter study comparing intravenous ocrelizumab with fingolimod in 187 patients aged 10-17 years with pediatric-onset relapsing-remitting multiple sclerosis. Earlier pediatric data from OPERETTA 1 showed that ocrelizumab was well tolerated, with no clinical relapses observed in patients aged 10-17 years treated for at least 96 weeks.Pediatric Safety Profile Earlier pediatric data suggested that ocrelizumab had a safety profile consistent with that established in adults. The established adult safety profile includes infusion-related reactions and infections among the key risks in routine use.Ocrevus should be administered under the supervision of physicians experienced in managing neurologic disease, with monitoring for potentially serious infusion reactions.The CHMP has recommended the change to the existing marketing authorization, but the opinion remains subject to a final decision by the European Commission. Updated prescribing information will be published by the EMA following the Commission’s decision.This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.