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News
Ocrelizumab (Ocrevus) is expanding its reach to younger MS patients globally. The FDA approved it in May 2026 for children aged 10+ with relapsing-remitting MS, and now Europe's EMA has recommended the same expansion. Both decisions are backed by the phase 3 OPERETTA 2 trial, which showed ocrelizumab outperformed fingolimod in reducing relapses and MRI lesion activity in pediatric patients.
Ocrelizumab (Ocrevus, Genentech/Roche) is becoming a go-to high-efficacy option for children with relapsing MS — and regulators on both sides of the Atlantic are taking notice. The FDA approved ocrelizumab in May 2026 for pediatric patients aged 10 and older weighing at least 55 lbs (25 kg) with relapsing-remitting MS (RRMS), making it a new alternative to fingolimod, which had been the only FDA-approved option for this age group. Most recently, the EMA's CHMP recommended extending Ocrevus's EU marketing authorization to children aged 10+ with active relapsing MS, pending a final European Commission decision.
Both approvals are anchored in the phase 3 OPERETTA 2 trial, a randomized, double-blind study of 187 patients aged 10–17 years. Ocrelizumab met its primary endpoint of noninferiority to fingolimod in annualized relapse rate and went further — achieving near-complete relapse suppression by week 24. Safety findings were consistent with the established adult profile.
By the Numbers:
Why it matters: Pediatric MS is aggressive — kids face frequent relapses and a high risk of long-term disability. Having a high-efficacy, well-tolerated option like ocrelizumab now available (or soon to be) in both the US and Europe could meaningfully change outcomes for this vulnerable population.
