CHMP Backs Roche's Ocrevus for Pediatric Relapsing MS, Citing 48% Relapse Reduction
核心洞察
The EMA's CHMP recommended approval of intravenous Ocrevus (ocrelizumab) for patients aged 10 years and older with relapsing forms of multiple sclerosis (搜索).
The positive opinion rests on the Phase 3 OPERETTA 2 trial, which tested Ocrevus against fingolimod, the current standard treatment for pediatric MS.
Ocrevus was non-inferior to fingolimod on relapse control and cut relapse risk by 48%, with 48% fewer new or enlarging T2 lesions.
The Committee for Medicinal Products for Human Use (搜索) (CHMP) of the European Medicines Agency (搜索) has recommended approval of Roche's Ocrevus (ocrelizumab) intravenous infusion for patients aged 10 years and older with relapsing forms of multiple sclerosis (搜索) (RMS). The European Commission will now review the opinion and is expected to issue a final decision on marketing authorization in the near future.
The recommendation covers an age group with substantial unmet need. At least 40,000 children and adolescents are living with MS worldwide, with roughly one-third of them in Europe, according to the Atlas of MS 2026. Roche noted that this population emphasizes the need for early high-efficacy MS treatment.
OPERETTA 2 Results
The positive opinion is based on results from the Phase 3 OPERETTA 2 study, which evaluated Ocrevus against fingolimod, described as the current standard treatment for pediatric MS. Findings were presented at the 2025 Congress of the European Committee for Treatment and Research in Multiple Sclerosis (搜索) in Barcelona.
Ocrevus demonstrated non-inferiority to fingolimod in controlling relapses and reduced the risk of relapses by 48% compared with fingolimod. The trial also showed superiority in reducing brain lesions, with a 48% reduction in new or enlarging T2 lesions and an 87% reduction in gadolinium-enhancing active T1 lesions.
The safety profile of Ocrevus in children and adolescents was consistent with its established profile in adults. No patients in OPERETTA 2 discontinued treatment due to adverse events.
Dosing and Mechanism
Ocrevus is a humanised monoclonal antibody designed to target CD20 (搜索)-positive B cells, a type of immune cell thought to be a key contributor to myelin and axonal damage in MS. The intravenous formulation is administered every six months. The initial dose consists of two 300 mg infusions given two weeks apart, followed by single 600 mg infusions every six months.
A subcutaneous formulation, marketed in the U.S. as Ocrevus Zunovo (ocrelizumab hyaluronidase-ocsq), is given as a single 920 mg subcutaneous injection every six months. Roche states that the IV and subcutaneous forms are the only therapies approved for both relapsing MS, including relapsing-remitting MS and active secondary progressive MS, and primary progressive MS.
Regulatory Sequence
The CHMP opinion follows U.S. regulatory action. The U.S. Food and Drug Administration (搜索) approved Ocrevus for pediatric RMS patients in May 2026.
Multiple sclerosis (搜索) affects more than 3 million people worldwide. Approximately 85% of patients are initially diagnosed with relapsing-remitting MS, while about 15% are diagnosed with the primary progressive form. Roche notes that despite the availability of high-efficacy therapies, over a third of MS patients remain on lower-efficacy therapy, and that slowing or stopping progression while simultaneously stopping relapses remains a high unmet need.
Neurology is a major focus of Roche's research and development, with more than a dozen medicines under investigation for neurological conditions including multiple sclerosis (搜索), spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer's disease, Huntington's disease, Parkinson's disease and Duchenne muscular dystrophy.