BLA for Four-Factor Human PCC Accepted for Review

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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