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MAY 16, 2018

FDA Granted a New Indication for Gilenya to Treat RMS in Children

By SPC News Staff

The FDA granted a new indication to fingolimod (Gilenya, Novartis) to treat children and adolescents with relapsing forms of multiple sclerosis (RMS), making it the first disease-modifying therapy (DMT) indicated for these patients.

Being able to use it in children from 10 years and older expands the age range for fingolimod, which was previously approved for patients aged 18 years and older with RMS. The FDA granted fingolimod breakthrough therapy designation for this pediatric