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.