CSL Behring Receives FDA Approval of Kcentra for Urgent Warfarin Reversal in Patients with Acute Major Bleeding

CSL Behring has announced that the U.S. Food and Drug Administration (FDA), has approved Kcentra™ (Prothrombin Complex Concentrate [Human]), the first non-activated 4-factor prothrombin complex concentrate (PCC) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (e.g., warfarin) therapy in adult patients with acute major bleeding.

The pivotal clinical trial showed that Kcentra met all efficacy and safety endpoints, including the endpoints of hemostatic efficacy and International Normalized Ratio (INR) reduction compared with plasma, the most widely used agent for warfarin reversal in the United States.

"Kcentra has been shown to restore the decreased vitamin K-dependent clotting factors significantly faster than plasma in patients on warfarin," said Ravi Sarode, M.D., Professor of Pathology and Director of Transfusion Medicine and Hemostasis Reference Laboratory at the University of Texas Southwestern Medical Center, and coordinating investigator for the Kcentra trial.

Each year, approximately three to four million people in the U.S. are treated with the oral anticoagulant warfarin 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. However, because of the deficiency in blood clotting factors induced by warfarin treatment, patients may experience severe bleeding. It is estimated that emergency departments in the U.S. see approximately 29,000 cases annually for warfarin-associated bleeding.

"FDA approval of Kcentra is an important advancement in warfarin reversal, as it provides medical professionals with a new tool that can efficiently stop major bleeding in patients for whom plasma may not be optimal," said Lynne Powell, Senior Vice President, North America Commercial Operations, CSL Behring. "Kcentra is CSL Behring’s fifth FDA product approval since 2009. This record of success further underscores our commitment to innovation and bringing therapies to market that effectively treat and manage serious medical conditions."

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. In more than 25 countries, CSL Behring markets Kcentra as Beriplex® or Confidex®.

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