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Biogen Idec Applies to FDA for Approval of BG-12 to Treat MS

February 29, 2012

Biogen Idec announced that the company has submitted a New Drug Application to the U.S. Food and Drug Administration for approval to market oral BG-12 (dimethyl fumarate) for the treatment of MS, based on positive results from several clinical trials involving people with relapsing-remitting MS.

Multiple sclerosis involves immune system attacks against brain and spinal cord tissues. Although its exact mechanism of action is not known, BG-12 is thought to inhibit immune cells and molecules and may be protective against damage to the brain and spinal cord.

BG-12 significantly reduced the proportion of people with MS who experienced relapses in the phase 3 DEFINE study of more than 1200 people with relapsing-remitting MS and significantly reduced the average number of annual MS relapses in the phase 3 CONFIRM trial of more than 1400 people with relapsing-remitting MS. Data from the DEFINE trial were presented at the 2011 joint meeting of the European and Americas Committee for Treatment and Research in MS, and data from both trials will be presented at the Annual Meeting of the American Academy of Neurology in April 2012; abstracts can be viewed on the meeting web site.

“If the FDA’s review of oral BG-12 finds it to be safe and effective, it would represent an important treatment advance for people with MS,” said Aaron Miller, MD, Chief Medical Officer of the National MS Society.

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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