17th March 2015
CSL Behring today announced that The Lancet has published results from a Phase III clinical study showing Kcentra® (Prothrombin Complex Concentrate [Human]) to be superior to plasma for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients needing an urgent surgery or invasive procedure. Kcentra is the first and only non-activated 4-factor prothrombin complex concentrate (4F-PCC) approved by the U.S. Food and Drug Administration (FDA) for this use and for the urgent reversal of warfarin therapy in adult patients with acute major bleeding.
Each year, approximately three to four million people in the U.S. use 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.1,2 Due to a 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.
"The results of the Phase III study published in The Lancet show that Kcentra is more effective than plasma for INR [international normalized ratio] reduction and periprocedural hemostasis in adults who are taking warfarin and require an urgent procedure," said lead study author Joshua N. Goldstein, M.D., Ph.D., attending physician in the Department of Emergency Medicine at Massachusetts General Hospital.
Results of the multicenter, open-label, phase IIIb randomized trial showed that in 168 evaluable patients, 90 percent of patients treated with Kcentra achieved effective hemostasis, compared to 75 percent of patients treated with plasma. Additionally, INR reduction to ≤1.3 at 30 minutes after the end of infusion was achieved in 55 percent of patients treated with Kcentra versus 10 percent of patients treated with plasma. Incidences of adverse events, serious adverse events, thromboembolic events, and deaths were similar between the Kcentra and plasma groups. In post-hoc analysis, the median time from start of infusion to start of urgent surgical procedure was shorter in the Kcentra group (3.6 hours [IQR 1.9–10.8]) than in the plasma group (8.5 hours [IQR 2.8–18.7]); (p=0.0098).
"CSL Behring has long been at the forefront of developing innovative protein therapies to help healthcare professionals treat patients with serious medical conditions," said Bill Campbell, Senior Vice President, North America Commercial Operations, CSL Behring. "Kcentra further underscores our commitment by providing physicians with a treatment option to prevent and manage the risks of excessive bleeding in patients on warfarin who need to undergo an urgent surgery or invasive procedure."
Kcentra was first approved for use in the U.S. in April 2013 and received a new technology add-on payment (NTAP) designation from the Centers for Medicare and Medicaid Services through September 2015. To be eligible for an NTAP, the product must be new and inadequately paid for under existing MS-DRGs, and must provide a significant clinical improvement over existing therapies.