Balfaxar, a warfarin reversal medication from Octapharma, receives FDA approval

FDA Approves Balfaxar, a Life-Saving Warfarin Reversal Drug

Source – Octapharma

More than 2.4 million individuals in the United States rely on warfarin, a blood thinner, to prevent clotting after experiencing a heart attack, stroke, or other severe thromboembolic events. However, the use of blood thinners comes with its own set of risks, making patients more susceptible to bleeding, especially during urgent surgeries or invasive procedures.

To address this risk, Octapharma developed a treatment that rapidly restores the blood’s ability to coagulate. Recently, the FDA approved their product called Balfaxar (prothrombin complex concentrate, human-lans). This treatment, already known as Octaplex in Europe and Canada, is designed for the urgent reversal of acquired coagulation factor deficiency caused by vitamin K antagonists like warfarin.

Balfaxar comes in the form of a lyophilized powder that can be reconstituted with sterile water for injection, using a new transfer device called Nextaro.

The FDA’s approval of Balfaxar was based on a Phase III clinical trial that compared its efficacy and safety with CSL Behring’s coagulation agent Kcentra. The study demonstrated that Balfaxar achieved effective hemostasis in 94.6% of patients, slightly outperforming Kcentra, which achieved 93.5% success.

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 primary objective was met at the prespecified interim analysis and the study was stopped due to statistically significant efficacy results indicating that Balfaxar was non-inferior to Kcentra. Balfaxar demonstrated effective hemostasis in 94.6% of patients versus 93.5% of patients for Kcentra. International Normalized Ratio (INR) reductions and vitamin K dependent coagulation factor increases supported the primary endpoint and PCC dosing and duration of infusion were also similar. The safety profile was similar between treatment arms and consistent with previous studies.ā€

– LEX-209 Principal Investigator Ravi Sarode, M.DĀ 

In addition to its current use, Octapharma is also exploring Balfaxar’s potential in treating major bleeding related to direct oral anticoagulant (DOAC) therapy, as mentioned in their 2022 annual report. DOAC drugs include well-known medications like Bristol Myers Squibb and Pfizer’s Eliquis, as well as Johnson & Johnson’s Xarelto.

The development and approval of Balfaxar offer a promising solution to address bleeding risks associated with blood-thinning therapies, providing patients with a safer option during critical medical interventions.

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