Genzyme Announces it Will Resubmit Lemtrada Application to the FDA - National Multiple Sclerosis Society

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Genzyme Announces it Will Resubmit Lemtrada Application to the FDA

April 7, 2014

Today (April 7) Genzyme, a Sanofi company, announced it will be resubmitting its application to the U.S. Food and Drug Administration for 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).  The company announced it intends to submit during the second quarter of 2014.

“We are encouraged by this development and will be monitoring the process closely as it moves forward,” commented Timothy Coetzee, PhD, Chief Advocacy, Services and Research Officer at the National MS Society.

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

About Multiple Sclerosis

Multiple sclerosis, an unpredictable, often disabling disease of the central nervous system, interrupts 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 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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