Octapharma's Prothrombin Complex Concentrate, Balfaxar®, Receives FDA Approval for Urgent Surgery and Invasive Procedures Warfarin Reversal
Thursday, July 27, 2023
Octapharma has announced the FDA approval of Balfaxar® (prothrombin complex concentrate, human-lans), which is marketed as octaplex® in Europe and Canada. This approval allows Balfaxar® to be used for urgently reversing acquired coagulation factor deficiency induced by vitamin K antagonist (VKA) therapy, such as warfarin, in adult patients who require urgent surgery or invasive procedures.
Balfaxar® is designed to restore blood coagulation by replenishing deficient clotting factors resulting from warfarin treatment. It 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 clinical trial LEX-209 (ClinicalTrials.gov Identifier: NCT02740335), which conducted a head-to-head comparison of Balfaxar® with a control 4F-PCC (Kcentra®). The Phase III study was conducted at 24 sites in the U.S. and Europe and involved 208 patients, with 105 receiving Balfaxar® and 103 receiving the control 4F-PCC. The trial successfully demonstrated that Balfaxar® was non-inferior to Kcentra® in terms of efficacy and safety, leading to an early termination of the study at the prespecified interim analysis.
Balfaxar® showed effective hemostasis in 94.6% of patients compared to 93.5% for Kcentra®, with supporting evidence from reductions in International Normalized Ratio (INR) and increases in vitamin K-dependent coagulation factors. The dosing and duration of infusion for Balfaxar® were similar to the control group, and both treatments exhibited a comparable safety profile, consistent with previous studies.
Balfaxar® comes in the form of a lyophilized powder for reconstitution, and it will be provided with sterile water for injection and a new transfer device called nextaro®. The nextaro® transfer device features an optimized vial housing for precentering during mounting and integrated filters for enhanced contamination protection, and it was preferred by healthcare professionals in an Octapharma user preference study.