The US FDA has approved ocrelizumab (Ocrevus, Genentech) intravenous infusion for children aged 10 years and older with relapsing-remitting multiple sclerosis (RRMS) who weigh at least 55 lbs (25 kg), the company announced.
The approval was supported by findings from the phase 3 OPERETTA 2noninferiority trial in pediatric-onset MS, ocrelizumab met its primary endpoint compared with fingolimod, demonstrating better tolerability and greater reductions in disease activity on brain imaging, as reported previously by Medscape Medical News.
Until now, fingolimod was the only FDA-approved treatment for RRMS in children. The OPERETTA 2 trial evaluated whether ocrelizumab could provide a safe and effective alternative to fingolimod for children with RRMS.
A total of 187 children aged 10-17 years were randomized (1:1) to receive either 600 mg of intravenous ocrelizumab every 24 weeks or 0.5 mg of oral fingolimod daily, with both groups receiving a matching placebo for the alternative.
Ocrelizumab reduced the annualized relapse rate by 48% compared with fingolimod (0.07 vs 0.14) after a median follow-up of more than 132 weeks.
Although relapse events increased gradually and at similar rates early in treatment, ocrelizumab achieved near-complete suppression of relapses beginning around week 24 and continuing through follow-up. In addition, 31% of relapses in the fingolimod group were considered severe compared with none in the ocrelizumab group.
Ocrelizumab was also associated with a 48% relative reduction in annualized new or enhancing T2 lesions compared with fingolimod (3.83 vs 7.28; P < .001). At week 24, fewer patients on ocrelizumab had new T2 lesions (6.5% vs 42.5%), and by week 96 the rate was 0% vs 41.4%.
At week 12, the proportion of patients with at least one T1 gadolinium-enhancing lesion was 87% lower with ocrelizumab than with fingolimod (4.3% vs 15.9%; P = .001).
The safety profile in pediatric patients was consistent with that seen in adults. Serious adverse events and serious infections were infrequent and balanced between groups. No patients receiving ocrelizumab stopped treatment due to adverse events, compared with three patients receiving fingolimod.
Ocrelizumab is approved in the US for adults with primary progressive MS or relapsing forms of MS — including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease — and now for RRMS in children 10 years of age and older who weigh 55 lbs (25 kg) or more.
The safety and efficacy of ocrelizumab in children younger than 10 years of age and weighing less than 55 lbs is unknown, the company said.
Full prescribing information is available online.
FUENTE: MEDSCAPE.COM
Cite this: FDA Approves Ocrelizumab for Pediatric Relapsing MS – Medscape – May 11, 2026
