FDA approves Novartis' MS drug Gilenya for adolescents

FDA approved Gilenya fingolimod from Novartis AG (NYSE:NVS; SIX:NOVN) to treat relapsing multiple sclerosis in patients ages 10 to 18. The drug, which is already marketed for the indication in adults, is the first approved pediatric MS treatment in the U.S.

The first-generation sphingosine 1-phosphate (S1P) receptor antagonist has breakthrough therapy status and was granted Priority Review. Patents for Gilenya, the first oral MS drug, are set to expire next year. Its approval for a pediatric indication could extend its patent protection by six months under section 505(a) of the Federal Food, Drug, and Cosmetic Act...