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FDA Approves Novartis Multiple Sclerosis Drug

White pills in a prescription bottle (


Novartis, an international pharmaceutical company, said today that the U.S. Food and Drug Administration (FDA) approved its drug Gilenya, an oral multiple sclerosis (MS) treatment. Gilenya (fingolimod) is the first drug available in the U.S. that treats relapsing forms of multiple sclerosis, the most common forms of the disease.

Novartis says the Gilenya approval was based on the largest clinical trial program ever submitted to date to the FDA for a new MS drug with 2,600 clinical trial patients, some of whom are in their seventh year of treatment. The submission included 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.

Gilenya does not cure MS, but it can help slow the build up of physical problems that MS causes. The National Multiple Sclerosis Society says MS affects over 400,000 Americans and more than 2.1 million people worldwide.

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