FDA extends review of Biogen’s haemophilia drug

The US Food and Drug Administration has extended the initial Prescription Drug User Fee Act (PDUFA) date for its review of Biogen Idec’s Biologics License Application (BLA) for its haemophilia B drug.

The drug, Alprolix, is Biogen’s investigational long-lasting recombinant factor IX Fc fusion protein candidate that is currently in late-stage clinical development for the treatment of hemophilia B. 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.

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 has extended the PDUFA date by three months to allow additional time for review of the marketing application.

Hemophilia B is a rare disease that impairs the ability of a person’s blood to clot. It is also a chronic, inherited disorder, which affects approximately 3000 people in the United States.

Alprolix is also under review by regulatory authorities in several countries, including Canada, Australia and Japan.

 

 

Related news:

Biogen says FDA extending review of hemophilia drug (Reuters)

Reference links:

Biogen press release

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