Balfaxar receives FDA nod for treating acquired coagulation factor deficiency

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.