FDA Approves Multiple Sclerosis Therapy for Use in Pediatric Patients

Officials with the FDA have approved fingolimod (Gilenya, Novartis) for the treatment of relapsing multiple sclerosis (MS) in pediatric patients aged 10 years and older, making it the first FDA-approved drug to treat MS in this population, according to a press release.

Fingolimod was initially approved by the FDA in 2010 to treat adults with relapsing MS. It has previously been granted priority review and breakthrough therapy designation for its newest indication.

According to the FDA, 2% to 5% of patients with MS experience symptoms before the age of 18 and estimates suggest that 8000 to 10,000 children and adolescents in the United States have MS. For most patients with MS, episodes of symptoms including worsening function are initially followed up with periods of remission, but over time patients may experience progressive decline in function and increased disability.

The approval is based on a clinical trial evaluating fingolimod’s efficacy in treating pediatric patients with MS. In the trial, 214 patients aged 10 to 17 years old were evaluated, comparing fingolimod to another MS drug, interferon beta-1a.

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