Fingolimod (FTY720)

Parent company: Novartis

Oral medication taken daily.

Blocks T cells from leaving lymph nodes, lowering their number in the blood and tissues; may reduce damage to nerves and enhance nerve repair.

Adverse events may include slowed heart rate, increased blood pressure, airway obstructions, and infection.

A 36-month Phase II study showed that 60 percent of RRMS patients remained relapse-free and a low rate of disease activity as observed on MRI. Patients are being recruited for the 24-month FREEDOMS Phase III study of low-dose and high-dose fingolimod versus placebo. Primary outcome measures are safety and tolerability, the proportion of relapse-free patients, and the burden of disease and inflammatory activity as measured by MRI.

The TRANSFORMS trial is now recruiting participants for its third phase. This 24-month study of the efficacy of fingolimod, as compared to Avonex in patients with a documented history of RRMS, has the primary outcome measure of a reduction of relapse rate; secondary measures will include frequency of relapses, inflammatory disease activity as measured on MRI, and time to progression of disability.