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# Octapharma NDA for Warfarin Reverser OK’d
- URL: https://www.fdaweb.com/octapharma-nda-for-warfarin-reverser-okd/
- Published: 2023-07-26T12:00:00.000Z
- Updated: 2026-09-14T18:46:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154963

FDA has approved an Octapharma NDA for Balfaxar (prothrombin complex concentrate) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (e.g., warfarin) therapy in adult patients needing urgent surgery or invasive procedures. 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 company says the drug “helps restore blood coagulation by replenishing the levels of clotting factors that are deficient due to warfarin therapy.”

Approval was based on data from the [LEX-209](https://c212.net/c/link/?t=0&l=en&o=3928502-3&h=1268488444&u=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT02740335&a=LEX-209&ref=fdaweb.com) clinical trial, which compared the efficacy and safety of Balfaxar head-to-head with a control 4F-PCC (Kcentra). “Balfaxar met the primary endpoint of hemostatic efficacy and was non-inferior to the comparator, Kcentra, in patients on a vitamin K antagonist undergoing urgent surgery with significant bleeding risk,” the company says.