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FDA delays decision on Biogen Idec's BG-12

October 19, 2012 1:28 AM UTC

FDA extended the PDUFA date by three months for an NDA from Biogen Idec Inc. (NASDAQ:BIIB) for BG-12 to treat multiple sclerosis (MS). The delay would move a potential decision into early next year; Biogen Idec had expected a decision by year end. According to the company, FDA needs more time to review the application, but the agency did not ask for additional studies. The oral dimethyl fumarate that activates the NF-E2-related factor 2 (Nrf2) pathway is also under review for the indication in the EU, Australia, Canada and Switzerland. Biogen Idec was down $4.22 to $149.56 on Thursday. ...