The U.S. Food and Drug Administration (FDA) has accepted Octapharma USA's Biological License Application (BLA) for octaplex®.
“Octaplex® is presently available in 75 countries worldwide and was first approved for use in Germany in 2003. We believe octaplex® can help fill a significant patient need.”
The FDA will evaluate the octaplex® BLA for the proposed indication of reversal of anticoagulation therapy 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 American College of Chest Physicians updated their guidelines in 2012 recommending the use of 4-factor PCCs for the urgent reversal of vitamin K antagonists, such as warfarin, in cases of major bleeding. In 2011, the British Committee for Standards in Haemotology provided guidance recommending all hospitals that manage patients on warfarin should have available a licensed 4-factor PCC.
Presently, 4-Factor PCC therapies are not marketed in the U.S. There are approximately 3.8 million U.S. patients on warfarin, an oral anticoagulant generally prescribed for the prevention of thrombosis and thromboembolism. Warfarin has a major bleed rate of 1.7% to 3.4%.
The BLA is supported by an open label study comparing octaplex® to the current U.S. standard of care, fresh frozen plasma, in patients taking a vitamin K antagonist (e.g. warfarin) and who required urgent surgery or an immediate invasive procedure. Two primary outcome measures were studied. The first primary efficacy endpoint was the correction of international normalized ratio (INR), a measure of the blood's tendency to clot, to <1.5 after the end of infusion. The second primary endpoint documented the number of intra-operative red blood cells transfused.
"We look forward to bringing octaplex® to the U.S. patient and medical communities," said Octapharma USA President Flemming Nielsen. "Octaplex® is presently available in 75 countries worldwide and was first approved for use in Germany in 2003. We believe octaplex® can help fill a significant patient need."
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