CSL Behring has announced that Kcentra (prothrombin complex concentrate [human]) has received the US Food and Drug Administration (FDA) approval for an expanded indication -- urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, for example, warfarin) therapy in adult patients needing an urgent surgery or other invasive procedure.
Kcentra, approved by the FDA in April 2013 for the urgent reversal of warfarin therapy in adult patients with acute major bleeding, is the only non-activated 4-factor prothrombin complex concentrate (4F-PCC) indicated in the U.S. for these uses.
Kcentra helps restore blood coagulation by replenishing the levels of clotting factors that were depleted by warfarin therapy. Kcentra contains four vitamin K-dependent factors: Factor II (prothrombin), Factor VII, Factor IX and Factor X, as well as antithrombotic Proteins C and S.
Warfarin is used each year by approximately three to four million people in the U.S. to prevent blood clots from forming following a stroke, heart attack, heart valve surgery, deep vein thrombosis/pulmonary embolism, or certain types of irregular heartbeat, such as atrial fibrillation.
Due to the deficiency in blood clotting factors induced by warfarin treatment, patients are at increased risk of bleeding, especially if undergoing an urgent surgery or invasive procedure.
CSL Behring North America commercial operations senior vice president Lynne Powell noted the company is committed to improving the lives of people with serious health conditions by continuously working to address unmet medical needs with novel therapies.
"The expanded indication for Kcentra in patients on warfarin therapy needing an urgent surgery or invasive procedure is another example of this commitment," Powell added.
