FDA approves CSL's Kcentra and accepts Octapharma Octaplex BLA for reversal of anticoagulation

The US Food and Drug Administration has approved Kcentra (prothrombin complex concentrate, human) from Germany-based CSL Behring, a subsidiary of Australia’s CSL Ltd (ASX: CSL), for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the USA.

Like plasma, Kcentra is used in conjunction with the administration of vitamin K to reverse the anticoagulation effect and stop the bleeding. Unlike plasma, Kcentra does not require blood group typing or thawing, so it can be administered more quickly than frozen plasma.

“The FDA’s approval of this new product gives physicians a choice when deciding how to treat patients requiring urgent reversal of VKA anticoagulation," said Karen Midthun, director, Center for Biologics Evaluation and Research, at the FDA, adding that “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.”