The Medical Letter on Drugs and Therapeutics
Oral Fingolimod (Gilenya) for Multiple Sclerosis
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The FDA has approved the marketing of fingolimod (Gilenya – Novartis) to reduce the frequency of clinical exacerbations and delay the accumulation of physical disability in patients with relapsing forms of multiple sclerosis (MS). Fingolimod is the first oral drug approved for this indication.

MECHANISM OF ACTION — Fingolimod is phosphorylated to fingolimod phosphate, which interacts with sphingosine 1-phosphate (S1P) receptors to block lymphocyte egress from lymph nodes, reducing the number of lymphocytes in peripheral blood and the central nervous system.1

CLINICAL STUDIES — A 24-month, randomized double-blind trial in 1272 patients with relapsing-remitting MS found that those taking fingolimod once daily had a significantly lower annualized relapse rate (the primary endpoint) than those on placebo (0.18 with 0.5 mg and 0.16 with 1.25 mg, vs. 0.40 with placebo). ... more      

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Title: Oral Fingolimod (Gilenya) for Multiple Sclerosis
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