Canadian families gain new therapy for children with relapsing MS
Twice-yearly Ocrevus infusion approved for youth 10 and older
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Following Health Canada's expanded approval of Ocrevus, young people with relapsing MS now have access to a second disease-modifying therapy.
- Health Canada approved Ocrevus for pediatric patients 10 and older with RRMS.
- Children with MS typically experience frequent relapses and rapid accumulation of neurological damage.
- The twice-yearly infusion therapy significantly reduces relapses and brain lesions compared to other treatments.
Children and teenagers in Canada with relapsing-remitting multiple sclerosis (RRMS) now have a second treatment option following Health Canada’s approval of the infusion therapy Ocrevus (ocrelizumab).
The regulatory decision extends the use of Ocrevus to patients 10 and older. Previously authorized in Canada only for adults, Ocrevus joins daily oral Gilenya (fingolimod) as the only approved disease-modifying therapies for RRMS patients 10 to 17 in the country.
Ocrevus was developed by Genentech, a subsidiary of Roche. Roche Canada stated that it will collaborate with both public and private insurance programs to ensure eligible young patients can access the intravenous therapy without delay.
“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,” Dan Edgcumbe, MD, vice president of medical and regulatory affairs at Roche Canada, said in a company press release. “This approval is a reflection of our continued effort to offer new treatment options to address the greatest unmet needs.”
The Canadian expansion follows a similar approval in the U.S., which cleared Ocrevus for pediatric RRMS patients 10 and older weighing at least 25 kg (55 pounds).
Addressing high disease activity in pediatric MS
MS occurs when the immune system mistakenly launches inflammatory attacks that damage nerve cells in the brain and spinal cord, causing a wide range of symptoms.
Canada reports some of the highest rates of MS worldwide, affecting approximately 90,000 residents, according to Roche Canada. While MS is predominantly diagnosed in adulthood, an estimated 2% to 10% of people with MS develop symptoms before age 18, a condition known as pediatric-onset MS (POMS). Canada also has among the highest rates of POMS worldwide.
Compared with adults, children with MS tend to experience more frequent relapses, which are episodes of new or worsening symptoms, alongside more areas of brain inflammation and damage, visible on scans as lesions. Because of this early disease activity, pediatric patients can accumulate physical disability much earlier in life.
“A childhood MS diagnosis shapes formative years of growth and development, and can affect their health, education, and future for decades to come,” said Pamela Valentine, PhD, president and CEO of 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.”
Ocrevus works by reducing the number of certain immune cells called B-cells that contribute to MS-related inflammation. The therapy is given by intravenous, or into-the-vein, infusion, with the first two doses administered two weeks apart and subsequent doses generally given every six months.
In Canada, Ocrevus is also conditionally approved for early primary progressive MS, meaning the treatment can be prescribed while its manufacturer provides additional evidence to confirm its benefits before full approval.
Clinical trial shows strong relapse and lesion control
Health Canada based its latest approval on data from the Phase 3 OPERETTA 2 trial (NCT05123703), which evaluated 187 children and teenagers with RRMS. The study directly compared Ocrevus infusions given every six months against daily Gilenya capsules over a two-year period.
Trial results showed that Ocrevus was at least as effective as Gilenya at controlling relapses, meeting the study’s primary goal. The annualized relapse rate, which measures the mean number of relapses per patient per year, was 48% lower with Ocrevus than with Gilenya.
MRI scans confirmed substantial reductions in disease activity. At two years, Ocrevus reduced the proportion of patients who developed new or enlarging MS lesions by 48%. It also lowered the proportion of those with lesions showing active inflammation at three months by 87%.
The medication’s safety in children and adolescents was consistent with previous adult data. Serious side effects and serious infections were rare and occurred at similar rates across both study groups. Furthermore, no patients discontinued Ocrevus because of side effects, whereas three participants discontinued Gilenya.
“Unlike adults living with MS, our pediatric patients have limited access to new treatments,” said Daniela Pohl, MD, professor of pediatric neurology at the Children’s Hospital of Eastern Ontario. “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.”
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