FDA extends PDUFA date for Biogen Idec's MS drug BG-12; Abbott and Reata's bardoxolone stalled

Shares of US biotech firm Biogen Idec (Nasdaq: BIIB) fell 3% to $149.50 in premarket trading yesterday, when the company said that the US Food and Drug Administration has extended the initial Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug Application for the marketing approval of BG-12 (dimethyl fumarate), the company’s oral therapeutic candidate for the treatment of multiple sclerosis (MS).

The three-month extension is a standard extension period, said Biogen, adding that the FDA has indicated that the extension of the PDUFA date is needed to allow additional time for review of the application. The agency has not asked for additional studies.

BG-12 is an investigational oral therapy in late-stage clinical development for the treatment of relapsing-remitting multiple sclerosis (RRMS), the most common form of MS. Dimethyl fumarate is the only currently known investigational compound for the treatment of RRMS that has experimentally demonstrated activation of the Nrf-2 pathway.