Roche’s Ocrevus Gains Positive CHMP Opinion for Pediatric Multiple Sclerosis in Europe
Roche (SIX: RO, ROP; OTCQX: RHHBY) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for the approval of Ocrevus® (ocrelizumab) intravenous (IV) infusion for children and adolescents aged 10 years and older living with relapsing forms of multiple sclerosis (RMS). The recommendation represents an important regulatory step toward expanding access to a high-efficacy treatment option for pediatric patients with multiple sclerosis (MS) in Europe.
The CHMP opinion now moves Ocrevus closer to a potential European approval for pediatric RMS. A final decision from the European Commission is expected in the near future. If approved, the expanded indication would provide an established disease-modifying therapy to younger patients whose MS can be associated with frequent relapses and significant disease activity.
The development also follows regulatory progress in the United States. In May 2026, the U.S. Food and Drug Administration (FDA) approved Ocrevus for pediatric patients with relapsing forms of multiple sclerosis. The positive CHMP opinion therefore represents another major milestone in Roche’s efforts to make Ocrevus available to younger people with RMS across major markets.
Addressing an Unmet Need in Pediatric Multiple Sclerosis
Multiple sclerosis is a chronic disease of the central nervous system in which the immune system attacks myelin and other components of the nervous system. While MS is more commonly diagnosed in adults, children and adolescents can also develop the disease.
Pediatric MS can present unique challenges because the disease occurs during important stages of physical, cognitive, educational and social development. Relapses can interrupt schooling and everyday activities, while ongoing disease activity may contribute to neurological disability over time.
Roche highlighted the need for effective treatment options for younger patients, noting that children and adolescents with MS can experience more frequent and severe relapses than adults.
Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development, said the positive CHMP opinion moves the company closer to addressing a longstanding treatment gap in Europe.
According to Garraway, pediatric patients and teenagers living with MS may face substantial disease activity, while available treatment options have historically lagged behind those available for adults. He emphasized that the potential pediatric use of Ocrevus is supported by extensive experience with the medicine in adults.
The potential European approval would build on approximately a decade of experience with Ocrevus in adult MS and extend the treatment to a younger patient population.
Phase III OPERETTA 2 Supports Regulatory Recommendation
The CHMP’s positive opinion is based on findings from the Phase III OPERETTA 2 study, which evaluated Ocrevus against fingolimod in pediatric patients with relapsing multiple sclerosis.
Fingolimod has been an established treatment option in pediatric MS, making the comparison clinically relevant for evaluating the effectiveness of Ocrevus in younger patients.
In the OPERETTA 2 study, Ocrevus demonstrated non-inferiority to fingolimod in controlling relapses. The treatment reduced the risk of relapse by 48% compared with fingolimod.
Beyond relapse control, the study also showed significant effects on measures of inflammatory disease activity in the brain. Ocrevus was associated with a 48% reduction in new or enlarging T2 lesions compared with fingolimod. The treatment also produced an 87% reduction in gadolinium-enhancing active T1 lesions.
These findings provide evidence that Ocrevus can reduce both clinical relapse activity and MRI-detected inflammatory activity in pediatric RMS.
The results are particularly relevant because MRI measures can provide an indication of ongoing inflammatory activity that may not always be immediately reflected through clinical symptoms. By demonstrating reductions across different measures of disease activity, the OPERETTA 2 findings support the potential role of Ocrevus as a high-efficacy treatment for pediatric patients.
Safety Profile Consistent With Adult Experience
Safety was another important component of the OPERETTA 2 evaluation. Roche reported that Ocrevus demonstrated a consistent safety profile in children and adolescents that was similar to the safety profile previously observed in adults.
Importantly, no patients in the pediatric study discontinued Ocrevus because of side effects.
The consistency of the safety findings with the established adult experience provides additional information for physicians and families considering treatment options for children and adolescents with RMS. Pediatric patients require careful monitoring because treatment decisions must take into account both immediate disease control and longer-term health and development.
The data from OPERETTA 2 therefore contribute to the evidence base supporting Ocrevus in younger patients, alongside the substantial clinical experience accumulated in adults.
Potential Importance of Early Disease Control
Dr. Brenda Banwell, MD, Chair of Pediatrics at Johns Hopkins Medicine, Pediatrician-in-Chief and Co-Director of the Johns Hopkins Children’s Center, highlighted the challenges associated with a pediatric MS diagnosis.
According to Banwell, children and adolescents with MS may experience unpredictable relapses that can require hospitalization and acute treatment. Such episodes can result in missed school days, interruptions to social activities and concerns about future disability.
She described extending Ocrevus to younger patients as an important step toward suppressing disease activity early, with the goal of preserving physical and cognitive health.
The emphasis on early disease control reflects the broader clinical consideration in pediatric MS. Because children diagnosed with MS have many years ahead of them, limiting disease activity early in the course of treatment can be an important consideration in managing the potential long-term impact of the disease.
The availability of high-efficacy treatment options for pediatric patients may therefore provide neurologists with additional flexibility when developing individualized treatment strategies.
Ocrevus and the Broader MS Treatment Landscape
Ocrevus is an established therapy for multiple sclerosis and has been used extensively in adult patients. The treatment targets CD20-positive B cells, a type of immune cell involved in the inflammatory processes associated with MS.
The medicine is administered through intravenous infusion. Its established use in adult MS has generated substantial clinical experience, while the OPERETTA 2 program has provided data specifically addressing treatment in younger patients.
The potential European pediatric indication would extend Ocrevus into an age group where treatment needs can differ from those of adults. Children and adolescents may require consideration of factors such as schooling, family life, physical development and long-term neurological health alongside conventional measures of relapse and disease activity.
The CHMP recommendation is therefore relevant not only from a regulatory perspective but also for the broader development of pediatric MS care in Europe.
Significant Pediatric MS Population in Europe
Roche estimates that at least 40,000 children and adolescents worldwide are living with multiple sclerosis, with approximately one-third of this population located in Europe.
Although pediatric MS represents a relatively small proportion of the overall MS population, the impact of the disease can be substantial for affected children, their families and healthcare systems.
Relapses can lead to hospital admissions and acute interventions, while periods of disease activity can interfere with education and normal childhood development. The potential availability of a high-efficacy treatment specifically supported by pediatric clinical data could therefore be significant for European MS specialists.
The OPERETTA 2 results provide clinical evidence that Ocrevus can control relapses while also reducing MRI measures of inflammatory activity compared with fingolimod.
Next Regulatory Step in Europe
The CHMP’s positive opinion is an important milestone, but it does not represent the final European regulatory decision. The recommendation will now proceed to the European Commission, which is expected to make a final decision on the marketing authorization in the near future.
If the European Commission grants approval, Ocrevus would become available for the treatment of pediatric patients aged 10 years and older with relapsing forms of multiple sclerosis in accordance with the approved European indication.
The decision would follow the FDA’s May 2026 approval for pediatric RMS, creating regulatory momentum for broader availability of Ocrevus among younger patients.
For Roche, the development further expands the company’s MS portfolio and builds on its long-term experience with Ocrevus in adult patients.
Expanding Treatment Options for Younger Patients
The positive CHMP opinion for Ocrevus reflects growing attention to the need for effective disease management in pediatric multiple sclerosis. The Phase III OPERETTA 2 findings demonstrated non-inferior relapse control compared with fingolimod, alongside significant reductions in new or enlarging T2 lesions and gadolinium-enhancing active T1 lesions.
The reported 48% reduction in relapse risk and substantial reductions in MRI measures of inflammatory activity provide evidence supporting Ocrevus as a potential treatment option for pediatric RMS.
At the same time, the reported safety findings were consistent with the established adult profile, with no pediatric patients discontinuing treatment because of side effects in the study.
With at least 40,000 children and adolescents estimated to be living with MS worldwide, including roughly one-third in Europe, the potential European authorization could broaden access to high-efficacy disease-modifying treatment for younger patients.
As the European Commission considers the CHMP recommendation, families, clinicians and the broader MS community will await the final regulatory decision. If approved, the pediatric indication would extend Roche’s Ocrevus treatment experience to patients aged 10 years and older and provide another option for addressing relapses and inflammatory disease activity earlier in the course of pediatric multiple sclerosis.
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.
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