Biogen Idec files BG-12 at FDA for Multiple Sclerosis

Biogen Idec has announced the company has submitted a New Drug Application (NDA) to the FDA for marketing approval of BG-12 (dimethyl fumarate), the oral therapeutic candidate for the treatment of Multiple Sclerosis (MS). The regulatory submission was based on BG-12�s comprehensive development program, in which BG-12 demonstrated significant reductions in MS disease activity coupled with favorable safety and tolerability in the Phase III DEFINE and CONFIRM studies.Biogen Idec plans to submit a Marketing Authorisation Application (MAA) for BG-12 to the European Medicines Agency (EMA) within the coming days.