FDA approves anticoagulant-reversal product

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug that reverses the effects of anticoagulant drugs in patients who have suffered acute major bleeding, the agency said.

The FDA announced the approval of CSL Behring's Kcentra (prothrombin complex concentrate [human]) for the urgent reversal of vitamin K antagonist, or VKA drugs such as warfarin.

Previously, the only treatment available for this use was plasma, according to the agency, but plasma must be frozen and requires thawing and blood group typing before use, while Kcentra does not, thus allowing for faster administration.

"The FDA's approval of this new product gives physicians a choice when deciding how to treat patients requiring urgent reversal of VKA anticoagulation," FDA Center for Biologics Evaluation and Research director Karen Midthun said. "Kcentra is administered in a significantly lower volume than plasma at recommended doses, providing an alternative for those patients who may not tolerate the volume of plasma required to reverse VKA anticoagulation."


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