Biogen Idec applies to FDA for approval of oral BG-12 to treat MS
Biogen Idec 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. BG-12 previously received “Fast Track” designation from the FDA, which should expedite its review.
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.
The MS Society of Canada will provide additional information on BG-12 as it becomes available.