Fingolimod for the treatment of relapsing multiple sclerosis

Abstract

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-β_1a. 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.

Keywords::

• disease-modifying therapy
• fingolimod
• relapsing multiple sclerosis
• sphingosine-1-phosphate receptor modulator

Financial & competing interests disclosure

B Singer was an investigator in the fingolimod FREEDOMS II and TRANSFORMS clinical trials. He has received honoraria from Novartis Pharmaceuticals Corporation for consulting and speaking. In addition, B Singer has received honoraria for consulting and/or speaking from Acorda Therapeutics, Bayer, Biogen-Idec, EMD Serono, Genentech, Genzyme, Pfizer and Teva. B Singer has also received research support from Acorda Therapeutics, Biogen-Idec, EMD Serono, Genzyme and Sanofi-Aventis. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Medical writing support for the preparation of this manuscript was funded by Novartis Pharmaceuticals Corporation and provided by Valerie P Zediak, PhD, and Erica S Wehner, RPh, CMPP, from Complete Healthcare Communications, Inc. (PA, USA).