Fingolimod for the treatment of relapsing multiple sclerosis.

Fingolimod 0.5 mg (Gilenya(™), Novartis Pharmaceuticals Corporation, FL, USA) is the first once-daily oral therapy approved for relapsing forms of multiple sclerosis (MS) in the USA and for rapidly evolving severe MS or highly active disease despite IFN-β treatment in Europe. An extensive clinical development program has established fingolimod as an effective therapy that reduces relapses by approximately half compared with placebo or intramuscular IFN-β1a. Over 2 years of postmarketing experience in >63,000 MS patients (with >73,000 patient-years of exposure) across the world has contributed to a well-characterized safety profile for fingolimod, and its side effects are manageable through patient monitoring. This article discusses the unique mechanisms of action of fingolimod in the immune and nervous systems, the key data underlying its efficacy and safety profile and perspectives on the role of fingolimod in current and future treatment strategies for MS.