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Octapharma secures FDA nod for warfarin reversal agent Balfaxar

More than 2.4 million people in the United States use warfarin to keep their blood from clotting after a heart attack, stroke or other serious thromboembolic complication.

But using a blood thinner carries risks of its own as patients become prone to bleeding, particularly during urgent surgery or other invasive procedures.

To combat the risk, Swiss plasma specialist Octapharma has developed a treatment that rapidly restores the blood’s ability to coagulate. On Wednesday, the FDA signed off on the company’s Balfaxar (prothrombin complex concentrate, human-lans).

Already marketed as Octaplex in Europe and Canada, Balfaxar is for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonists such as warfarin.

Balfaxar, which is a lyophilized powder for reconstitution, is provided with sterile water for injection by way of a new transfer device called Nextaro. 

The drug earned approval based on a phase 3 trial that compared its efficacy and safety with CSL Behring’s coagulation agent Kcentra. The study showed that Balfaxar achieved effective hemostasis in 94.6% of patients, versus 93.5% of patients for Kcentra.

Octapharma also is testing Balfaxar in the treatment of major bleeding related to direct oral anticoagulant (DOAC) therapy, the 40-year-old private company said in its 2022 annual report. Drugs in that class include Bristol Myers Squibb and Pfizer’s Eliquis, and Johnson & Johnon’s Xarelto.