FDA Denies Approval for Lemtrada™ (alemtuzumab) for Relapsing MS - National Multiple Sclerosis Society

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FDA Denies Approval for Lemtrada™ (alemtuzumab) for Relapsing MS

December 30, 2013

The U.S. Food and Drug Administration has denied approval at this time for Lemtrada™ (alemtuzumab, Genzyme, a Sanofi Company) as a therapy for relapsing MS. According to a company press release, the FDA has taken the position that one or more additional clinical trials would be needed for marketing approval of Lemtrada. The company plans to appeal the agency’s decision.

Lemtrada is given by infrequent intravenous infusion – for 5 days initially and for 3 days one year later. Details regarding its potential benefits and risks from two phase III trials can be found here. Lemtrada is currently approved in Europe, Canada and Australia.

“This is disappointing news, given the need for more therapeutic options for people with MS living in the United States,” stated Timothy Coetzee, PhD, Chief Advocacy, Services and Research Officer at the National MS Society.

During a November FDA advisory committee meeting (link to Dec 30 2013 press release) about Lemtrada, the committee heard public testimony from people living with MS and patient advocacy groups, including the National MS Society. The Society’s testimony addressed the need for more therapeutic options for people with MS and the importance of empowering people with MS to make their own informed treatment decisions.

The Society will continue to monitor this process and update its constituents of any news.

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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