Novartis announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to fingolimod (Gilenya) for the treatment of patients aged ≥10 years with relapsing multiple sclerosis (MS).

Gilenya is already approved to treat relapsing forms of MS in adults. The latest designation was based on data from the Phase 3 randomized, controlled PARADIGMS study that compared the safety and efficacy of Gilenya vs interferon beta-1a in children and adolescents with relapsing MS. 

Patients treated with Gilenya experienced an 82% reduction in annualized relapse rate over a period of up to 2 years vs interferon beta-1a (P<0.001). The safety characteristics with Gilenya were similar to those seen in previous clinical studies evaluating adults. 

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Gilenya, a sphingosine 1-phosphate receptor modulator, works by blocking the capacity of lymphocytes to egress from lymph nodes, thus reducing the number of lymphocytes in peripheral blood; its mechanism is thought to involve decreased lymphocyte migration into the central nervous system (CNS).

Gilenya is available as 0.5mg strength capsules in 7- and 30-count packages.

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