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Sanofi Genzyme Announces: FDA Accepts Its Resubmitted Application for Lemtrada

May 30, 2014

Today (May 30) Sanofi Genzyme announced that the U.S. Food and Drug Administration had accepted for review the company’s resubmission of an application seeking approval of Lemtrada™ (alemtuzumab) as a treatment for relapsing MS in the United States. The company’s previous application was denied approval in December 2013 (read more).  According to a company press release, additional analyses and information have been provided to the agency, and the FDA’s review is expected to take about six months.

The Society will continue to provide updates as we learn more information.

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis, and there is currently no cure for MS. 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. An estimated 1 million people live with MS in the United States. Most people with MS are diagnosed between the ages of 20 and 50, and it affects women three times more than men.

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