Biogen Idec is seeking marketing approval from the US Food and Drug Administration (FDA) for recombinant factor VIII Fc fusion protein (rFVIIIFc) therapy to treat hemophilia A.
The company has submitted a biologics license application (BLA) to the US regulatory body based on the data from registrational Phase III hemophilia A study called A-LONG.
Biogen Idec hemophilia therapeutic area chief medical officer and global medical affairs senior vice president Glenn Pierce said as the patients treated with rFVIIIFc in Phase III study were able to inject rFVIIIFc once-weekly to twice-weekly which signifies the potential reduction of the prophylactic injections by 50 to 100 per year.
"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," Pierce added.
Recombinant FVIIIFc belongs to new class of long-lasting clotting factor therapies being developed against hemophilia A.
According to Biogen Idec, the half-life of rFVIIIFc facilitates prophylactic dosing once to twice a week.
