Because of its potent efficacy and oral route of administration, the approval of fingolimod as treatment for relapsing-remitting multiple sclerosis (MS) was highly anticipated. The therapeutic and adverse effects are mediated by modulation of sphingosine 1-phosphate receptors. Fingolimod inhibits the egress of lymphocytes from lymph nodes and may also have direct effects on the central nervous system. The clinical trials that led to the approval of fingolimod demonstrated benefit on relapses, disability progression, magnetic resonance imaging (MRI) activity, and brain volume loss in treatment-aïve and previously treated patients with relapsing-remitting MS. The use of fingolimod in clinical practice has been limited by concerns for cardiac effects, infection, and macular edema as
well as the relative lack of long-term safety data for this
drug with a novel mechanism of action. Additional clinical trial and postmarketing data suggest that fingolimod is a safe, effective, and well-tolerated treatment option when patients are selected and monitored appropriately.Until recently, all therapeutic options for RRMS required parenteral administration. Despite
excellent long-term safety profiles, patient compliance with first-line drugs—interferon beta (IFNβ) and glatiramer acetate (GA)—is limited by modest efficacy, frequent injections, and bothersome side effects. The U.S. Food and Drug Administration (FDA) approval of fingolimod (FTY720; Gilenya, Novartis, Basel, Switzerland) in September 2010, the first oral disease-modifying therapy, generated much interest among both patients and physicians. full story: http://www.medscape.com/viewarticle/805134_1