FDA approves Gilenya for pediatric relapsing MS

May 14, 2018
The U.S. Food and Drug Administration has approved Gilenya (fingolimod) for the treatment of children and adolescents from 10 to less than 18 years of age with relapsing forms of multiple sclerosis, making it the first disease-modifying therapy approved for these patients. This expands the age range for Gilenya, which was previously approved for patients aged 18 years and older with RMS. 

The approval of Gilenya for younger patients was supported by PARADIGMS, a double-blind, randomized, multicenter Phase III safety and efficacy study of fingolimod versus interferon beta-1a, designed specifically for children and adolescents with RMS. The primary endpoint demonstrated that fingolimod reduced the rate of relapses (annualized relapse rate) by approximately 82 percent during a period of up to two years compared to interferon beta-1a intramuscular injections in children and adolescents (ages 10 and older) with relapsing MS. The safety profile of Gilenya in this study was overall consistent with that seen in previous clinical trials in adults. In this study, while more adverse events were reported in the interferon beta-1a group, severe adverse events were reported at a higher frequency in fingolimod-treated patients.

While MS is mostly diagnosed in adults, children and adolescents with the chronic disease often experience more frequent relapses and brain lesions than adults with MS.

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