FDA pushes review date for Biogen blood drug

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FDA extended the review time for Biogen Idec's Alprolix, a candidate for hemophilia B, by three months, the company said today. The biotech added that it submitted “additional information related to the validation of a manufacturing step for Alprolix,” and due to the timing of that submission, the agency extended its PDUFA date to allow more time to review. Hemophilia B is a rare, inherited disorder that impairs the blood's ability to clot. Alprolix is also under review in Canada, Australia and Japan. Biogen Idec also has a long-acting recombinant coagulation factor pending approval for the treatment of hemophilia A. That drug, to be sold under the name Eloctate, was also delayed 90 days; its PDUFA date is coming up in 1Q14. Both products have orphan-drug status in the US.

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