NDA Submitted for BG-12 for Multiple Sclerosis
Biogen Idec announced that it has submitted a New Drug Application (NDA) to the FDA for marketing approval of BG-12 (dimethyl fumarate) for the treatment of multiple sclerosis (MS).
BG-12 demonstrated significant reductions in MS disease activity coupled with favorable safety and tolerability in the Phase 3 DEFINE and CONFIRM studies, two global, placebo-controlled Phase 3 clinical trials that evaluated 240mg of BG-12, administered either twice a day or three times a day, for two years.
BG-12 (dimethyl fumarate) is an investigational oral therapy known to activate the Nrf-2 pathway. Research suggests that BG-12 has the potential to reduce the activity and impact of inflammatory cells on the Central Nervous System (CNS) and induce direct cytoprotective responses in CNS cells. These effects may enhance the CNS cells' ability to mitigate the toxic inflammatory and oxidative stress that plays a role in MS pathophysiology.
For more information call (617) 679-2000 or visit www.biogenidec.com.