Genentech’s Ocrevus has received FDA approval for pediatric patients aged 10 years and older with relapsing multiple sclerosis, supported by Phase 3 OPERETTA II data showing strong relapse and MRI lesion control.
Written By: Samiksha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
Genentech, a member of the Roche Group, has received U.S. Food and Drug Administration (FDA) approval for intravenous (IV) Ocrevus to treat relapsing-remitting multiple sclerosis (RRMS) in pediatric patients aged 10 years and older who weigh at least 55 pounds (25 kg). The approval expands the therapy’s use beyond adults and provides a new high-efficacy treatment option for children and adolescents living with multiple sclerosis (MS).
The approval was supported by results from the Phase 3 OPERETTA II study (NCT05123703), which compared Ocrevus with fingolimod, previously the only FDA-approved treatment for pediatric RRMS. Ocrevus demonstrated noninferiority to fingolimod in reducing annualized relapse rate (ARR) and showed superior MRI outcomes, reducing new or enlarging T2 lesions by 48% and gadolinium-enhancing T2 lesions by 87% versus fingolimod.
The safety profile in pediatric patients was consistent with previous adult studies. Serious adverse events and serious infections were infrequently reported and balanced between treatment groups. No patients receiving Ocrevus discontinued treatment due to adverse events, while three patients in the fingolimod group withdrew from treatment.
Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development at Genentech, said the approval helps in addressing the longstanding lack of high-efficacy treatment options for pediatric MS patients in the United States. He added that the availability of Ocrevus for younger patients could help reduce relapses and potentially improve long-term outcomes through earlier disease control.
Emily Blosberg, founder of Mr. Oscar Monkey and a patient diagnosed with MS at age 15, said the approval gives children and adolescents earlier access to an FDA-approved high-efficacy therapy that may help in controlling relapses and brain lesion development before long-term neurological damage occurs.
According to the company, approximately 5,000 to 10,000 children and adolescents in the United States are living with pediatric-onset MS. Multiple sclerosis is a chronic neurological disease affecting more than 2.9 million people worldwide and is associated with progressive disability over time. Approximately 85% of patients are initially diagnosed with relapsing-remitting multiple sclerosis, while about 15% have primary progressive multiple sclerosis (PPMS).
Ocrevus is currently approved for relapsing forms of MS in adults, PPMS in adults, and now pediatric RRMS patients aged 10 years and older weighing at least 55 pounds (25 kg). The company noted that Ocrevus remains the only FDA-approved treatment for PPMS.
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About the Writer
Samiksha Vikram Jadhav (LinkedIn) is a B. Pharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She specializes in pharma market research, with a focused interest in mergers and acquisitions, strategic partnerships, and global pharma and biotech deals. Her work centers on analyzing industry transactions, market positioning, and business strategies, translating complex developments into clear, accurate, and insightful scientific and commercial reporting.