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FDA Extends Review Deadline for Hemophilia Drug Alprolix
Fusion protein delays breakdown of immunoglobulin (December 2)
The FDA has extended the initial Prescription Drug User Fee Act (PDUFA) date for its review of the biologics license application (BLA) for Aprolix, an investigational recombinant factor IX Fc fusion protein candidate for the treatment of patients with hemophilia B. The PDUFA date has been extended by 3 months, which is the standard extension period.
In response to a request from the FDA, the drug’s developer (Biogen Idec) submitted additional information related to the validation of a manufacturing step for Alprolix. Because of the timing of this submission, the FDA extended the PDUFA date to allow additional time for review of the marketing application.
Alprolix is an investigational fully recombinant, long-lasting clotting factor therapy in late-stage clinical development for the treatment of hemophilia B. The product uses Fc fusion technology, which takes advantage of a naturally occurring pathway that delays the breakdown of the protein immunoglobulin G1 (IgG1) 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 the drug circulates in the body.
Source: Biogen Idec; December 2, 2013.