Biogen
Idec BIIB 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
See full press release
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