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FDA Accepts Biogen's Application for Longer-Lasting FVIII Product

April 1, 2013

On March 12, 2013 Biogen Idec announced that the company submitted a Biologics License Application (BLA) to the FDA for the marketing approval of recombinant factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A. We have not yet been notified by the FDA of the BLA acceptance for rFVIIIFc. On March 4, 2013 Biogen Idec announced that the FDA accepted the company’s BLA for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B and granted the company a standard review timeline.

"In our phase 3 study, patients treated with rFVIIIFc were able to inject rFVIIIFc once-weekly to twice-weekly, which creates the potential for those currently on prophylactic treatment to reduce injections by 50 to 100 per year,” said Biogen in a press release. “Moreover, patients currently treating bleeding episodes could potentially dose prophylactically once per week and maintain significant protection from bleeding with about the same total number of injections each year they use to treat bleeding episodes today."

 

Source: The Boston Globe, March 4, 2013