Health Canada approves (Pr)Ocrevus® (ocrelizumab) for treating pediatric relapsing-remitting multiple sclerosis

• The intravenous formulation of Ocrevus (Ocrevus IV) addresses a critical need in pediatric multiple sclerosis (MS) as a treatment option for children as young as 10 years old.
• In the Phase III OPERETTA 2 study, Ocrevus IV demonstrated non-inferiority in relapse control and a statistically significant reduction in brain lesions compared to fingolimod,^[1] which is the only other approved treatment for pediatric MS in Canada.
• Roche Canada will work closely with federal, provincial, territorial and private payers to support timely access to Ocrevus IV for eligible pediatric patients.

MISSISSAUGA, ON, Nov. 3, 2026 /CNW/ -- Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that on October 23, 2026, Health Canada approved Ocrevus IV, also known as ocrelizumab for intravenous infusion, for the treatment of pediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (RRMS).^[1] 

"Unlike adults living with MS, our pediatric patients have limited access to new treatments. Given the high MS disease activity observed in pediatric MS and the associated accrual of irreversible neurological damage at a relatively young age, having a new treatment option available for these patients is a meaningful development," said Dr. Daniela Pohl, Professor of Pediatric Neurology, Children's Hospital of Eastern Ontario (CHEO).

Multiple sclerosis (MS) is a disease that affects the central nervous system, which includes the brain, spinal cord and optic nerves. Canada has one of the highest rates of MS in the world, with an estimated 90,000 Canadians living with the disease.^[2] Between two and 10 per cent of MS patients are estimated to experience symptoms before age 18, and Canada also has among the highest rates of pediatric-onset MS (POMS) in the world.^[3] POMS is often associated with higher relapse rates, greater number of MRI lesions, poor cognitive outcomes, and patients reaching disability milestones at a younger age compared to their adult-onset counterparts. ^[3,4]

"A childhood MS diagnosis shapes formative years of growth and development, and can affect their health, education, and future for decades to come," said Dr. Pamela Valentine, President and CEO, MS Canada. "We are pleased to see the approval of Ocrevus for pediatric MS. It can help young people access effective treatment at a critical stage of their disease, when it may have the greatest impact on their future."

Health Canada's authorization of Ocrevus IV for pediatric patients with RRMS is based on the Phase III OPERETTA 2 study, which demonstrated that Ocrevus was non-inferior to fingolimod, which is the only other approved treatment for pediatric MS, in reducing the annualized relapse rate (48 per cent risk reduction versus fingolimod).^[1,5] On MRI endpoints, Ocrevus demonstrated a significant reduction in new or enlarging T2 lesions (48 per cent reduction versus fingolimod) and gadolinium-enhancing T1 lesions (87 per cent reduction versus fingolimod). The safety profile of Ocrevus IV in pediatric patients was similar to that seen in adult patients. Serious adverse events and serious infections were infrequently observed and were similar between treatment groups. No adverse events led to treatment withdrawal in the Ocrevus group, and three patients withdrew in the fingolimod group.^[5] 

"Roche Canada is dedicated to providing timely access to innovative treatments for every Canadian living with multiple sclerosis, supporting people across all ages and stages of their disease," said Dr. Dan Edgcumbe, Vice President of Medical and Regulatory Affairs, Roche Canada. "This approval is a reflection of our continued effort to offer new treatment options to address the greatest unmet needs."

Roche Canada is committed to working with federal, provincial, territorial and private payers to support timely access to Ocrevus for eligible pediatric patients who may benefit from this treatment.

About Relapsing-Remitting Multiple Sclerosis (RRMS)

Multiple sclerosis (MS) is a neurological disease that affects the central nervous system, which includes the brain, spinal cord, and optic nerves. In MS, the immune system mistakenly targets myelin, the protective layer surrounding nerve fibres. When myelin is damaged, communication between the brain and the rest of the body can be disrupted, leading to a range of symptoms and, over time, contributing to disease progression.^[2]

Relapsing-remitting multiple sclerosis, or RRMS, is the most common form of MS at diagnosis.^[6] It is characterized by relapses, which are episodes of new or worsening neurological symptoms, followed by periods of partial or complete recovery, known as remission. Approximately 85 to 90 per cent of people living with MS are initially diagnosed with RRMS.^[6] Compared to adult patients with MS, children with MS face a heavier inflammatory burden, characterized by greater magnetic resonance imaging (MRI) lesion accumulation and an annualized relapse rate (ARR) 2.81 times higher in the first years following diagnosis.^[4]

MS symptoms vary from person to person, but may include fatigue, balance problems, weakness, numbness or tingling, vision changes, bladder or bowel issues, and cognitive or mood changes.^[2]

About Ocrevus

Ocrevus is a recombinant humanized monoclonal antibody. Monoclonal antibodies are proteins that bind to a unique site, called an antigen, on cells. Ocrevus binds to an antigen, called CD20, which is present at high levels on certain cells of your immune system. Ocrevus works on the immune system so that it may not attack the nervous system.

Ocrevus is administered by intravenous infusion every 6 months. In pediatric patients aged 10 years and older, the recommended dose is administered according to body weight. The initial dose is split into two separate, equal IV infusions administered 2 weeks apart depending on the patient's body weight. Patients that weigh between 25 and 35 kg should receive a 300 mg dose, and those that weigh 35 kg or more should receive a 600 mg dose. Subsequent doses of Ocrevus thereafter are administered as a single 300 mg or 600 mg IV infusion every six months depending on the patient's body weight. Patients who start on a 300 mg dose and subsequently reach a stable body weight of 35 kg or more should be switched to the 600 mg dose. A minimum interval of 5 months should be maintained between each dose of Ocrevus.^[1]

About the Phase III OPERETTA 2 study

OPERETTA 2 is a Phase III, randomized, double-blind, double-dummy, parallel-group, multicentre study to evaluate the safety and efficacy of ocrelizumab administered by IV infusion every 24 weeks compared with fingolimod taken orally once a day, in children and adolescents with RRMS aged ≥ 10 and < 18 years.

About Roche Canada

Roche Canada is a healthcare company that unites leading science and technology across diagnostics, medicines and digital solutions to prevent, stop and cure diseases.

We focus on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology to provide real and positive change for patients, the people they love, and the professionals who care for them.

Roche was founded in Basel, Switzerland in 1896 and began its journey in Canada in 1931. Today, Roche Canada employs nearly 2,000 people at its offices in Mississauga, Ontario, in Laval, Quebec, and across the country.

For more information, please visit www.RocheCanada.com or follow Roche Canada on LinkedIn.

References

1. Ocrevus (ocrelizumab) Product Monograph; October 23, 2026.
2. MS Canada. What is Multiple Sclerosis? Available from: https://mscanada.ca/intro-to-ms/what-is-multiple-sclerosis. Accessed on October 20, 2026.
3. Yusuf FLA, Asaf A, Marrie RA, Li P, McKay K, Zhao Y, Zhu F, Maxwell C, Tremlett H. Incidence and prevalence of paediatric-onset multiple sclerosis in two Canadian provinces: a population-based study representing over half of Canada's population. Journal of Neurology, Neurosurgery & Psychiatry. 2024;95:229-234.
4. Aljomah LS, Yeh EA. Pediatric multiple sclerosis: Improving outcome through high-efficacy therapies. Neurotherapeutics. 2025;22(4):e00631.
5. 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 (#O130). Presented at: ECTRIMS 2025; 24-26 September 2025; Barcelona, Spain.
6. MS Canada. Types of MS. Available from: https://mscanada.ca/intro-to-ms/types-of-multiple-sclerosis. Accessed on October 20, 2026. 

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SOURCE Hoffmann-La Roche Limited (Roche Canada)

Media Contact: Roche Canada: Marise Varanda, Communications Manager, [email protected], 416-464-5672