US and EU regulatory authorities accept oral BG-12 marketing applications for review

Today Biogen Idec (NASDAQ: 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 (MS). The U.S. Food and Drug Administration (FDA) has accepted Biogen Idec’s New Drug Application (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 (EMA) has validated Biogen Idec’s Marketing Authorisation Application (MAA) for review of BG-12 in the European Union.

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. 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.

About BG-12

BG-12 (dimethyl fumarate) is an investigational oral therapy under regulatory review for the treatment of MS. BG-12 is the only currently known investigational compound for the treatment of MS that has experimentally demonstrated activation of the Nrf-2 pathway. In 2011, Biogen Idec announced positive data from DEFINE and CONFIRM, two global, placebo-controlled Phase 3 clinical trials that evaluated 240 mg of BG-12, administered either twice a day or three times a day, for two years. BG-12 is currently being evaluated in a long-term extension study, ENDORSE.