FDA Greenlights Balfaxar for Warfarin Reversal in Urgent Surgery & Invasive Procedures

The US Food and Drug Administration (FDA) has approved Balfaxar (prothrombin complex concentrate, human-Ians) for the immediate reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (such as warfarin) therapy in adult patients who need an urgent surgery or invasive procedures.Balfaxar is a human plasma-derived, nonactivated four-factor prothrombin complex concentrate (4F-PCC) containing the coagulation factors II, VII, IX, and X and antithrombotic proteins C and S. It helps restore blood coagulation by replenishing the levels of clotting factors, which are deficient in patients undergoing warfarin therapy.
The approval was based on data from the phase 3, randomized, double-blind, noninferiority LEX-209 study, in which 208 patients were randomly assigned to receive a single dose of Balfaxar (n = 105) or control  (control 4F-PCC; n = 103). At about 30 minutes post-infusion, 78.1% of patients who received Balfaxar achieved International Normalized Ratio (INR) of 1.5 or less. None of the patients had their surgery canceled for inadequate INR correction.

Back to the list