Octapharma announced that Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) received FDA approval for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures.
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.
The FDA approval is supported by the clinical trial LEX-209 (ClinicalTrials.gov Identifier: NCT02740335), which compared the efficacy and safety of Balfaxar® head-to-head with a control 4F-PCC (Kcentra®). The Phase III, randomized, double-blind, multicenter study was performed at 24 sites in the US and Europe and randomized 208 patients to Balfaxar® (N=105) or control 4F-PCC (N=103).
More than 2.4 million US patients are prescribed warfarin to prevent blood clots from forming following a heart attack, heart valve surgery, stroke, deep vein thrombosis/pulmonary embolism, or for certain types of irregular heartbeat (atrial fibrillation). The main side effect of warfarin is an increased risk of bleeding particularly for patients undergoing urgent surgery or invasive procedures.
Balfaxar®, a lyophilized powder for reconstitution, will be provided with sterile water for injection and the new transfer device, nextaro®. The transfer device includes an optimized vial housing that enables precentering of the vial during mounting, and optimized contamination protection with two integrated filters. Nextaro® was preferred by healthcare professionals versus a widely used, competitive transfer device in an Octapharma user preference study.(4)
To study Balfaxar® further in other clinical scenarios, Octapharma is recruiting for two additional Phase III studies:
- LEX-210: Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor (ClinicalTrials.gov Identifier: NCT04867837)
- LEX-211: Active-control Randomised Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery (ClinicalTrials.gov Identifier: NCT05523297)
For more information on LEX-210 and LEX-211, please visit ClinicalTrials.gov.
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