More on Gilenya® as the first disease-modifying therapy for pediatric relapsing multiple sclerosis

Stuart SchlossmanMS Drug Therapies, Pediatric MS

In May 2018, Novartis announced FDA approval of Gilenya® as the first disease-modifying therapy for the treatment of children and adolescents 10 to less than 18 years of age with relapsing forms of multiple sclerosis (RMS), making it the first disease-modifying therapy indicated for these patients[2].


This approval expands the age range for Gilenya, which was previously approved for patients aged 18 years and older with RMS. Gilenya was granted Breakthrough Therapy designation by the FDA in December of 2017 for this pediatric indication.


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