FDA expands indication of Kcentra-CSL Behring

The FDA has given approval for an expanded indication of Kcentra (prothrombin complex concentrate), from CSL Behring, for use in 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 other invasive procedure. The approval was based on a Phase IIIb study which included 168 patients on Vitamin K antagonist therapy who required urgent replacement of their clotting factors due to the need for an urgent surgery/invasive procedure.

Kcentra was superior to plasma in achieving the endpoints of hemostatic efficacy for the time period from the start of infusion until the end of the urgent surgery or other invasive procedure (89.7 percent of patients treated with Kcentra versus 75.3 percent treated with plasma) and INR reduction (to less than or equal to 1.3) at 30 minutes after the end of infusion (55.2 percent of patients treated with Kcentra versus 9.9 percent of patients treated with plasma).