- Roche Canada has received Health Canada approval for Ocrevus IV (ocrelizumab) to treat children aged 10 years and older with relapsing-remitting multiple sclerosis (RRMS), expanding treatment options for pediatric patients.
- The approval is based on the Phase III OPERETTA 2 trial, where Ocrevus demonstrated non-inferiority to fingolimod, the only other approved pediatric MS treatment in Canada, with a 48% reduction in annualized relapse risk.
- Ocrevus also reduced new or enlarging T2 brain lesions by 48% and gadolinium-enhancing T1 lesions by 87% versus fingolimod. Its safety profile was similar to that observed in adults.
- The approval addresses an important treatment gap, as pediatric MS can involve higher relapse rates and early neurological damage. Roche will work with public and private payers to support timely access across Canada.
Takeaways:
Health Canada’s approval expands Roche’s Ocrevus market to pediatric patients, addressing a significant unmet need in the multiple sclerosis treatment landscape. The positive Phase III OPERETTA 2 results, particularly the reduction in relapses and brain lesions compared with fingolimod, could strengthen Ocrevus’ competitive position in pediatric MS. The approval also creates an opportunity for Roche to expand its patient base and reinforce its presence in the Canadian MS market, although broader uptake will depend on reimbursement and payer access decisions.
Source: CA Newswire
