FDA green light for Octapharma's Balfaxar

The US Food and Drug Administration (FDA) has granted approval of Balfaxar (prothrombin complex concentrate, human-lans) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, eg, warfarin) therapy in adult patients with need for urgent surgery or invasive procedures.

Developed by privately-held Swiss biotech Octapharma, the product is marketed in Europe and Canada as octaplex.

The company explained that Balfaxar helps restore blood coagulation by replenishing the levels of clotting factors that are deficient due to warfarin therapy. Balfaxar is a non-activated four factor prothrombin complex concentrate (4F-PCC) containing vitamin K-dependent factors: Factor II (prothrombin), Factor VII, Factor IX and Factor X, as well as antithrombotic proteins C and S.