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

If confirmed by the European Commission, the decision would extend Ocrevus’ high-efficacy anti-CD20 MS therapy to paediatric patients in Europe.

Rhea-AI Summary

Roche (RHHBY) received a positive CHMP recommendation to approve Ocrevus for children and adolescents with relapsing multiple sclerosis.

The opinion covers paediatric patients aged 10 years and older with relapsing forms of MS, with a final decision by the European Commission expected in the near future. The recommendation is based on the Phase III OPERETTA 2 trial, where Ocrevus reduced relapse risk by 48% versus fingolimod and achieved greater suppression of brain inflammation, with new or enlarging T2 lesions reduced by 48% and gadolinium-enhancing T1 lesions reduced by 87%.

Safety in paediatric patients was consistent with the established Ocrevus profile in more than 525,000 treated adults, with no treatment discontinuations due to side effects.

Positive

• Relapse control: OPERETTA 2 showed a 48% relapse risk reduction vs fingolimod in paediatric RMS.
• Lesion reductions: new/enlarging T2 lesions -48% and gadolinium-enhancing T1 lesions -87% vs fingolimod.
• Safety: paediatric safety profile aligned with adults, with no discontinuations due to side effects.
• Regulatory progress: CHMP positive opinion is a key step toward EU approval for paediatric RMS.
• Market expansion: at least 40,000 children and adolescents live with MS worldwide, about one-third in Europe.

Negative

• None.

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• Ocrevus addresses a critical need in paediatric neurology as the first high- efficacy anti-CD20 treatment option for people with MS 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 lesions¹
• Safety in children and adolescents was aligned with the established safety profile of Ocrevus across more than 525,000 adult patients globally¹

Basel, 18 September 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Ocrevus® (ocrelizumab) intravenous (IV) infusion for the treatment of paediatric patients aged 10 years and older with relapsing forms of multiple sclerosis (RMS). The U.S. FDA approved Ocrevus for paediatric RMS patients in May 2026. A final decision from the European Commission is expected in the near future.

“Children and teens living with multiple sclerosis experience more frequent and severe relapses than adults, yet their treatment options have lagged behind,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “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.”

"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,” said Dr. Brenda Banwell, MD, Chair of Pediatrics, Johns Hopkins Medicine, Pediatrician-in-Chief and Co-Director, Johns Hopkins Children’s Center. “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."

The CHMP's positive opinion is based on the Phase III OPERETTA 2 study, which showed that Ocrevus was non-inferior to fingolimod (the current standard treatment in paediatric MS) at controlling relapses, reducing the risk of relapses by 48% compared with fingolimod. In OPERETTA 2, Ocrevus was superior at reducing brain inflammation, showing significant reductions in new or enlarging T2 lesions (-48%) and gadolinium-enhancing active T1 lesions (-87%). Ocrevus demonstrated a consistent safety profile in children and teens similar to that seen in adults, with no patients stopping treatment due to side effects.¹

At least 40,000 children and adolescents are living with MS worldwide, with roughly one-third in Europe, emphasising the need for early high-efficacy MS treatment.²

About Ocrevus® (ocrelizumab)
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 (nerve cell insulation and support) and axonal (nerve cell) damage. Ocrevus IV and Ocrevus subcutaneous (SC; marketed as Ocrevus Zunovo® [ocrelizumab hyaluronidase-ocsq] in the U.S.) 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.

About multiple sclerosis
Multiple sclerosis is a chronic disease that affects more than 3 million people worldwide. People with all forms of multiple sclerosis experience disease progression from the beginning of their disease. Therefore, an important goal of treating multiple sclerosis is to slow, stop and ideally prevent progression as early as possible.

Approximately 85% of people with multiple sclerosis are initially diagnosed with relapsing-remitting multiple sclerosis (RRMS). Relapsing forms of the disease (RMS) include RRMS and active secondary progressive MS, and people with RMS experience relapses and worsening disability over time. Primary progressive multiple sclerosis (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with multiple sclerosis are diagnosed with the primary progressive form of the disease. Until the FDA approval of Ocrevus®, there had been no FDA-approved treatments for PPMS, and Ocrevus is still the only approved treatment for PPMS. Despite the availability of high-efficacy therapies, over a third of MS patients remain on lower-efficacy therapy today. Slowing or stopping progression while simultaneously stopping relapses remains a high unmet need in MS.

About Roche in Neurology
Neurology is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new diagnostics and treatments that help improve the lives of people with chronic and potentially devastating diseases globally.

Roche is investigating more than a dozen medicines for neurological conditions, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy. Roche Diagnostics has developed a broad range of approved and investigational tools, including digital and blood-based tests and cerebrospinal fluid (CSF) assays, aiming to more effectively detect, diagnose and monitor neurological conditions. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neurology today.

About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.

Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.

Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Banwell B, et al. Efficacy and Safety of Ocrelizumab Compared With Fingolimod in Paediatric Relapsing- Remitting MS: Results of the Phase III OPERETTA 2 Study. Presented at the 2025 Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS); 26 September 2025; Barcelona, Spain. 
[2] MS International Federation. The Atlas of MS 2026: A global update on MS prevalence, incidence, and the gaps that remain. September 2026. Available from: http://www.msif.org/wp-content/uploads/2026/09/Atlas-Epidemiology-report-text-core-data-2026-FINAL.pdf

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Attachment

• Media Release Ocrevus Paediatric CHMP English

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

Which paediatric patients would be eligible for Ocrevus if EU approval is granted?

The CHMP opinion supports use of Ocrevus IV infusion in paediatric patients aged 10 years and older with relapsing forms of multiple sclerosis (RMS), which include relapsing-remitting MS and active secondary progressive MS.

What is the dosing regimen for Ocrevus intravenous (IV) and subcutaneous (SC) formulations?

Ocrevus IV is given every six months, with an initial dose of two 300 mg infusions two weeks apart, followed by single 600 mg infusions every six months. Ocrevus SC (marketed in the U.S. as Ocrevus Zunovo) is administered as a single 920 mg subcutaneous injection every six months.

How does Ocrevus work in multiple sclerosis?

Ocrevus is a humanised monoclonal antibody targeting CD20-positive B cells, a type of immune cell thought to contribute to damage of myelin (nerve cell insulation and support) and axons (nerve cells). By depleting these B cells, Ocrevus aims to reduce inflammatory activity and limit nervous system damage in MS.

What is the regulatory status of Ocrevus for paediatric RMS outside the EU?

The U.S. FDA approved Ocrevus for paediatric RMS patients in May 2026. In Europe, the medicine currently awaits a final decision from the European Commission following the CHMP’s positive opinion.

How common is paediatric multiple sclerosis globally and in Europe?

At least 40,000 children and adolescents are estimated to be living with MS worldwide, with roughly one-third of these patients in Europe, underscoring the need for early high-efficacy treatment options.

For which forms of multiple sclerosis is Ocrevus currently approved in general?

Ocrevus IV and Ocrevus SC are the only therapies approved for both relapsing forms of MS (RMS)—including relapsing-remitting MS, active secondary progressive MS, and clinically isolated syndrome in the U.S.—and primary progressive multiple sclerosis (PPMS). Ocrevus remains the only approved treatment for PPMS.