NDA Accepted for BG-12 for Multiple Sclerosis
Biogen Idec announced that the FDA has accepted for filing the company's New Drug Application (NDA) for BG-12 (dimethyl fumarate) for the treatment of multiple sclerosis (MS).
Biogen Idec's regulatory applications for BG-12 were based on a comprehensive clinical development program in which BG-12 demonstrated significant reductions in MS disease activity coupled with favorable safety and tolerability in two pivotal Phase 3 clinical trials.
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.