Fingolimod Wins Breakthrough Designation for Pediatric Multiple Sclerosis

The FDA has granted Breakthrough Therapy designation to Fingolimod for treating children with relapsing multiple sclerosis.

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 (<.001). The safety characteristics with Gilenya were similar to those seen in previous clinical studies evaluating adults.

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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Novartis multiple sclerosis therapy fingolimod granted FDA Breakthrough Therapy designation for pediatric MS [press release]. East Hanover, NJ: Novartis. Published December 18, 2017. Accessed December 19, 2017.

This article originally appeared on MPR