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Fingolimod for the treatment of multiple sclerosis: a review of the evidence from the FREEDOMS and TRANSFORMS studies

Bhupendra O Khatri, John F Kramer

Fingolimod (Gilenya®) is the first oral immunomodulating drug approved for relapsing–remitting multiple sclerosis. Its novel mechanism of action inhibits the egress of autoreactive B and T cells from lymph nodes, thus preventing them from crossing into the CNS. Two recent large Phase III clinical trials both met their primary end points clearing the way for approval by the US FDA in September 2010. Despite robust clinical efficacy, safety concerns arose in both trials, including, but not limited to, increased risk of infection, cardiac issues and a higher incidence of cancer. Further long-term data will clarify these safety issues to enable clinicians to feel comfortable when prescribing fingolimod on a routine basis. This article will review the clinical trial data from the Trial Assessing Injectable Interferon versus FTY720 Oral in Relapsing–Remitting Multiple Sclerosis (TRANSFORMS) and FTY720 Research Evaluating Effects of Daily Oral therapy in Multiple Sclerosis (FREEDOMS) studies.