Multiple sclerosis (MS) is a chronic autoimmune disorder of the central nervous system with unknown etiology. The first-line therapies for the most common form of this disease, relapsing-remitting multiple sclerosis have been interferon β and glatiramer acetate. These drugs reduce relapse rates by about 30 per cent and are administrated either subcutaneously or intramuscularly. At present, only injectable drugs are available for treating multiple sclerosis. Fingolimod (FTY720/Gilenya; Novartis) represents a new generation of drugs with a unique mechanism of action involving sphingosine 1-phosphate receptor modulator activity. Gilenya was drug approved by US FDA on September 2010 and is indicated for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability. It is the first orally drug for this indication. The recommended dose of Gilenya is 0.5 mg orally once daily. Gilenya 0.5 mg reduced relapses by 52 per cent at one year compared with interferon β (Avonex) and has prospectively shown a benefit in reducing brain atrophy. The approval process of the drug in the EU countries is likely to be completed by the middle of 2011.