FDA extends review of Biogen hemophilia B drug

Mon, 12/02/2013 - 9:19am
The Associated Press

Biogen Idec said Monday the U.S. Food and Drug Administration (FDA) extended its review of Alprolix, a drug designed to treat hemophilia B.

Biogen Idec said the FDA extended its review by three months. The move came after the agency asked Biogen for more information about validation of part of the Alprolix manufacturing process. The extension will allow the FDA to review that information.

Hemophilia is a rare, inherited disease that affects blood clotting. Those with the disease don't have enough of a blood clotting protein called factor VIII.

Biogen Idec is seeking approval for new treatments for both hemophilia A and hemophilia B. Hemophilia A occurs in approximately one out of every 5,000 male births, while hemophilia B is less common and can affect both men and women.



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