Biogen Idec (BIIB) announced that U.S. and EU regulatory authorities have accepted the company's marketing applications for the review of BG-12 (dimethyl fumarate), an oral therapeutic candidate for the treatment of multiple sclerosis or MS.
Biogen noted that the U.S. Food and Drug Administration or FDA has accepted the company's New Drug Application or NDA for marketing approval of BG-12 in the United States and granted the company a standard review timeline.
In addition, the European Medicines Agency or EMA has validated Biogen Idec's Marketing Authorisation Application or MAA for review of BG-12 in the European Union.
Biogen Idec said its 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.
Biogen Idec announced that it submitted an NDA to the FDA and an MAA to the EMA in the first quarter of 2012. The company also recently submitted regulatory applications in Canada and Switzerland.
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