Octapharma USA has announced the US Food and Drug Administration (FDA)’s approval of Balfaxar (prothrombin complex concentrate, human-lans), a treatment for urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy. This approval marks a new opportunity for adult patients who urgently need surgery or invasive procedures.

Balfaxar, a non-activated four factor prothrombin complex concentrate (4F-PCC), replenishes the levels of clotting factors that warfarin therapy depletes. It contains vitamin K-dependent factors such as Factor II (prothrombin), Factor VII, Factor IX, and Factor X, in addition to antithrombotic Proteins C and S.

The FDA approval was based on the results of the clinical trial LEX-209, a Phase III, randomized, double-blind, multicenter study, comparing the efficacy and safety of Balfaxar with a control 4F-PCC (Kcentra). Conducted at 24 sites in the U.S. and Europe, the trial randomized 208 patients to Balfaxar (N=105) or control 4F-PCC (N=103).

Octapharma USA President, Flemming Nielsen, expressed confidence that Balfaxar will be a valuable treatment option for medical providers seeking to swiftly restore patients’ coagulation. “Octapharma is committed to providing patients with life-saving and life-enhancing therapies for critical care medicine,” Nielsen said.

Balfaxar, presented as a lyophilized powder for reconstitution, will be supplied with sterile water for injection and a new transfer device called nextaro. The device offers precentering of the vial during mounting and contamination protection with two integrated filters.

  Balfaxar, Flemming Nielsen, Octapharma, Octapharma USA, US FDA, US Food and Drug Administration, USA