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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 disease of the central nervous system. Currently there is no cure. Symptoms vary from person to person and may include disabling fatigue, mobility challenges, cognitive changes, and vision issues. An estimated 1 million people live with MS in the United States. Early diagnosis and treatment are critical to minimize disability. Significant progress is being made to achieve a world free of MS.

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The National MS Society, founded in 1946, is the global leader of a growing movement dedicated to creating a world free of MS. The Society funds cutting-edge research for a cure, drives change through advocacy and provides programs and services to help people affected by MS live their best lives. Connect to learn more and get involved: nationalMSsociety.org, Facebook, X, formerly known as Twitter, Instagram, YouTube or 1-800-344-4867.

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