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Fast FDA Review Expected for Application to Market Siponimod for Secondary Progressive MS

October 8, 2018

Novartis has announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s application for marketing approval of oral siponimod for the treatment of adults with secondary progressive MS. This follows positive results from a phase 3 trial, results of which were previously announced and published. The company has arranged an expedited review of this application by the FDA, and expects the agency to act on the application in early 2019.

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.


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