US FDA delays Alprolix approval

The US Food and Drug Administration (has extended the initial Prescription Drug User Fee Act (PDUFA) date for the review of US biotech firm Biogen Idec’s (Nasdaq: BIIB) Biologics License Application (BLA) for Alprolix (recombinant factor IX Fc fusion protein).

Alprolix, which is under development with Swedish Orphan Biovitrum (STO: SOBI), is Biogen’s investigational long-lasting recombinant factor IX Fc fusion protein candidate for hemophilia B. The PDUFA date has been extended by three months, which is the standard extension period, the company noted.

Biogen submits additional data

In response to a request from FDA, Biogen Idec submitted additional information related to the validation of a manufacturing step for Alprolix. Due to the timing of this submission, the FDA extended the PDUFA date to allow additional time for review of the marketing application.