FDA approves first oral MS drug, Novartis' fingolimod

FDA has approved the oral multiple sclerosis (MS) treatment fingolimod (Gilenya, Novartis), 0.5 mg daily, as a first-line treatment for relapsing forms of multiple sclerosis. The approval makes fingolimod the first oral treatment indicated for relapsing forms of MS available in the United States.

Fingolimod reduces the frequency of MS relapses (flare-ups) and helps slow the buildup of some of the physical problems caused by the disease. Fingolimod has a well-studied safety and tolerability profile, which has been characterized in more than 2,600 clinical trial patients, some of whom are in their seventh year of treatment, with more than 4,500 patient-years of experience.

The approval was based on the largest clinical trial program ever submitted to FDA for a new MS drug, and it included combined data from clinical studies showing significant efficacy in reducing relapses, the risk of disability progression, and the number of brain lesions detected by magnetic resonance imaging, a measure of disease activity, in people with relapsing forms of MS.

Fingolimod is the first in a new class of drugs called sphingosine 1-phosphate receptor (S1PR) modulators.

Novartis is actively pursuing regulatory approval of fingolimod in Europe and other parts of the world, said Trevor Mundel, MD, global head of development for Novartis Pharma AG.