Roche's Ocrevus Approved for Pediatric Multiple Sclerosis

Basel, 18 September 2026 - Roche, a global healthcare company, announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Ocrevus® (ocrelizumab) for the treatment of children and adolescents aged 10 years and older with relapsing forms of multiple sclerosis (RMS). This marks a significant advancement in the field of paediatric neurology, as Ocrevus is the first high-efficacy anti-CD20 treatment option for individuals as young as 10 years old.

In the Phase III OPERETTA 2 study, Ocrevus demonstrated non-inferiority in relapse control and superiority over fingolimod in suppressing brain lesions. Specifically, Ocrevus reduced the risk of relapses by 48% compared with fingolimod. Additionally, the therapy showed significant reductions in new or enlarging T2 lesions by -48% and gadolinium-enhancing active T1 lesions by -87%. The safety profile of Ocrevus in children and adolescents was consistent with the established safety profile seen in more than 525,000 adult patients globally.

The CHMP's positive opinion is based on the OPERETTA 2 study, which was presented at the 2025 Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain. According to the study, Ocrevus was well-tolerated, with no patients stopping treatment due to side effects.

Roche's Chief Medical Officer and Head of Global Product Development, Levi Garraway, MD, PhD, commented, "Children and teens living with multiple sclerosis experience more frequent and severe relapses than adults, yet their treatment options have lagged behind. The positive CHMP opinion brings us closer to bridging a longstanding gap in Europe, offering young people with MS a high-efficacy therapy backed by a decade of adult experience."

Dr. Brenda Banwell, Chair of Pediatrics at Johns Hopkins Medicine, added, "Living with a paediatric MS diagnosis means that children and adolescents must navigate a complex condition with unpredictable relapses that require hospital admission and acute therapies, lead to missed days of school and social activities, and face the potential for future disability. Extending Ocrevus, a proven treatment for adults, to younger patients is an important step forward to suppress disease activity early on, with the goal of preserving their physical and cognitive health."

Multiple sclerosis affects more than 3 million people worldwide, with approximately 85% of individuals initially diagnosed with relapsing-remitting multiple sclerosis (RRMS). Approximately 15% of people with multiple sclerosis are diagnosed with the primary progressive form of the disease, which is marked by steadily worsening symptoms but typically without distinct relapses or periods of remission.

Roche, founded in Basel, Switzerland in 1896, is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. The company's commitment to tackling healthcare challenges that place the greatest strain on patients, families, communities, and healthcare systems is evident in its ongoing research and development efforts in neurology and other areas.

Ocrevus is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin and axonal damage. Ocrevus IV and Ocrevus subcutaneous (SC) are the only therapies approved for both RMS (including relapsing-remitting multiple sclerosis [RRMS] and active, secondary progressive multiple sclerosis [SPMS], as well as clinically isolated syndrome [CIS] in the U.S.) and primary progressive multiple sclerosis (PPMS). Both Ocrevus IV and SC are administered every six months. The initial IV dose is given as two 300 mg infusions two weeks apart, with subsequent doses given as single 600 mg infusions. Ocrevus SC is given as a single 920 mg subcutaneous injection every six months.

Roche's focus on neurology as a major research and development area underscores its dedication to pursuing groundbreaking science to develop new diagnostics and treatments for chronic and potentially devastating diseases globally.