Alprolix PDUFA Date Delayed

The FDA has extended the initial Prescription Drug User Fee Act (PDUFA) date for its review of Biogen Idec‘s 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.

Alprolix is a fully recombinant, long-lasting clotting factor therapy in late-stage clinical development for the treatment of hemophilia B. Alprolix uses Fc fusion technology, which takes advantage of a naturally occurring pathway that delays the breakdown of IgG1 (protein commonly found in the body) and cycles it back into the bloodstream. The Fc portion of IgG1 is fused to factor IX in Alprolix and is thought to be responsible for the prolonged time Alprolix circulates in the body. While Fc fusion is an established technology that has been used for more than 15 years, Biogen Idec is the only company to apply it in hemophilia.