FTY720 in multiple sclerosis: the emerging evidence of its therapeutic value.

INTRODUCTION

Multiple sclerosis is a demyelinating disease of the central nervous system which can cause severe disability and has profound effects on patients' quality of life over several decades. Although there is no cure for the disease, recently developed disease-modifying agents have modest effects on the impact of disease progression. There is therefore a need for a new, effective, and well-tolerated treatment for multiple sclerosis and FTY720 (an orally administered immunomodulatory compound with a novel mechanism of action) is one of a number of agents being evaluated for the treatment of this disease.

AIMS

The objective of this article is to assess the therapeutic potential for FTY720, now in phase II clinical trials, for the treatment of multiple sclerosis through a review of the published evidence.

EMERGING EVIDENCE

There is good evidence that FTY720 achieves immunomodulation as shown by a reversible redistribution of peripheral blood lymphocytes after oral administration. Two meeting abstracts have been published showing results obtained with FTY720 in a 12-month phase II clinical trial in patients with active relapsing multiple sclerosis. There is modest evidence that FTY720 significantly improves both patient-oriented (relapse rate) and disease-oriented outcomes (inflammatory disease activity). There is good evidence that FTY720 is well tolerated.

PROFILE

Based on these early results from the clinical development program, FTY720 has the potential to be an effective disease-modifying agent for the treatment of multiple sclerosis. Further results from ongoing multinational phase III studies are awaited.