Biogen Idec Receives Notification from FDA of PDUFA Date Extension for ALPROLIX™
Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) has extended the initial Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics License Application (BLA) for ALPROLIX™, the company’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.
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.