The Food and Drug Administration (FDA) has expanded the use of Gilenya (fingolimod; Novartis) to include the treatment of children and adolescents aged 10 to <18 years with relapsing forms of multiple sclerosis (MS). This marks Gilenya as the first disease-modifying therapy approved for this patient group. 

Gilenya, a sphingosine 1-phosphate receptor modulator, was initially approved in 2010 for the treatment of relapsing MS in patients aged ≥18 years.

The FDA’s decision was based on data from the Phase 3 PARADIGMS study (N=215) which evaluated the safety and efficacy of oral fingolimod vs interferon beta-1a injection in pediatric patients aged 10 to <18 years with relapsing MS. The primary endpoint of the study was the frequency of relapses in patients treated up to 24 months (annualized relapse rate [ARR]); secondary endpoints included the number of new or newly enlarged T2 lesions, gadolinium-enhancing T1 lesions, and the safety and pharmacokinetic profiles of fingolimod. 

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Treatment with fingolimod resulted in approximately an 82% reduction in ARR (P< .001) over a 2-year period vs interferon beta-1a in children and adolescents with relapsing MS. More patients in the fingolimod group remained relapse-free after 24 months of treatment vs the interferon beta-1a group (86% vs 46%). The overall safety profile of fingolimod was consistent with previous clinical trial findings in adults. The interferon beta-1a group reported more adverse events but the fingolimod group showed a higher incidence of severe adverse events. 

“For the first time, we have an FDA-approved treatment specifically for children and adolescents with multiple sclerosis,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Multiple sclerosis can have a profound impact on a child’s life. This approval represents an important and needed advance in the care of pediatric patients with multiple sclerosis.”

Gilenya is available in 0.25mg and 0.5mg strength gel caps. 

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