Fingolimod and cardiac risk: latest findings and clinical implications.

Overview

Fingolimod is an oral medication approved for the treatment of relapsing multiple sclerosis (MS). It is unique compared with other approved disease-modifying therapies for MS in that it is the first oral agent and it has a novel mechanism of action. In clinical trials and postmarket use, it demonstrates clear therapeutic efficacy. However, it is associated with certain risks including cardiac concerns. The recent reports of cardiac events potentially associated with the drug prompted a regulatory agencies review of the use of fingolimod for MS in the USA and Europe. After completion of their review, the US Food and Drug Administration and the European Medicines Agency concluded that its benefits outweighed the risks. However, certain recommendations were made for appropriate patient selection for fingolimod and for more cautious first-dose monitoring. We review the use of fingolimod for MS in light of the recently reported potential cardiac risks. We conclude that with appropriate patient selection and careful monitoring, it appears to have a favorable benefits/risks profile and can be a valuable treatment option for relapsing MS. Continued postmarketing surveillance and data from the extension phase of its clinical trials will be very important in understanding the long-term efficacy and safety of fingolimod and to help determine its place in the treatment algorithm for multiple sclerosis.