Octapharma U.S.A. announced that the FDA has accepted for review its Biologic License Application (BLA) for octaplex for the reversal of anticoagulation in patients undergoing vitamin K antagonist therapy with the need for urgent surgery or invasive procedures. Octaplex is a four-factor, human prothrombin complex concentrate (PCC) consisting of factors II, VII, IX, and X in a ratio close to 1:1:1:1, as well as the thrombo-inhibitors, proteins C and S.
The submission was supported by an open label study comparing octaplex to the current standard of care, fresh frozen plasma, in patients taking a vitamin K antagonist and who require urgent surgery or an immediate invasive procedure. The two primary efficacy endpoints were the correction of international normalized ratio (INR), a measure of blood’s tendency to clot, to <1.5 after the end of infusion, and the number of intra-operative red blood cells transfused.
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