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

Last month, Biogen Idec announced that the US Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for the marketing approval of ELOCTATE™ a recombinant factor VIII (FVIII) Fc fusion protein for the treatment of hemophilia A.


According to a Biogen press release posted on May 13th, 2013, ELOCTATE is the first hemophilia A product candidate in a new class of long-lasting clotting factor therapies.


“ELOCTATE has the potential to improve adherence by reducing the number of intravenous injections needed to prevent bleeds, which is an important need for people with hemophilia A,” said Glenn Pierce, MD, PhD, senior vice president of Global Medical Affairs and chief medical officer of Biogen Idec’s hemophilia therapeutic area. “For those people currently on preventive—or prophylactic—treatment, ELOCTATE provides the potential to reduce the number of intravenous injections by 50 to 100 per year.”


The ELOCTATE BLA was based on results from A-LONG, the largest registrational phase 3 clinical study in hemophilia A to date. In the A-LONG study, patients who injected ELOCTATE weekly or twice weekly had fewer bleeds. This is in contrast to the current prophylactic regimen for patients with severe hemophilia A, who typically infuse three times per week or every other day to maintain a sufficient level of FVIII in their bloodstream to prevent bleeds.


Source: Biogen press release dated May 13, 2013