FDA approves Ocrevus for relapsing-remitting MS in pediatric patients 10 years of age and older
In the OPERETTA II study, Ocrevus demonstrated noninferiority to fingolimod (previously the only FDA-approved treatment for RRMS in pediatrics) in reducing the annualized relapse rate (ARR) and superiority in reducing new or enlarging T2 lesions (48% reduction vs fingolimod) and gadolinium-enhancing T2 lesions (87% reduction vs fingolimod). The safety profile in pediatric patients was consistent with that observed in adult patients. Serious adverse events and serious infections were infrequently observed and well balanced; no adverse events led to treatment withdrawal in the Ocrevus group, and three patients withdrew in the fingolimod group.