Parent company: Novartis Pharmaceuticals Corporation
- Oral medication taken daily.
- Fingolimod blocks potentially damaging T cells from leaving lymph nodes, lowering their number in the blood and tissues. It may reduce damage to nerves and enhance nerve repair. Data in the animal model of MS (EAE) suggest that fingolimod may have neuroprotective effects.
- 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 had a low rate of disease activity as observed on MRI. The FREEDOMS Phase III studies of low-dose and high-dose fingolimod versus placebo are ongoing. An extension study, FREEDOMS II, is evaluating long-term safety, tolerability and efficacy; all participants are receiving fingolimod. There have been two deaths from Herpes virus infection in the FREEDOMS trials.
- The INFORMS study of fingolimod is the only PPMS trial now ongoing. The study will evaluate the effect of fingolimod relative to placebo on delaying the time to sustained disability progression. It will evaluate safety and tolerability, effects on MRI parameters, and patient-reported outcomes over the 36 months of the study.
- The TRANSFORMS trial is a 24-month study of the efficacy of fingolimod as compared to Avonex in individuals with RRMS. Individuals on Avonex experienced an average of 0.33 relapses per year (or one relapse every three years), while those on fingolimod had 0.16 - 0.20 relapses per year (or roughly one relapse every five to six years). A higher dosage level of fingolimod was associated with fewer relapses.