Andexxa (Coagulation Factor Xa [recombinant], inactivated-zhzo)May 8, 2018
Andexxa is an inactive modified recombinant factor Xa molecule that competes with circulating levels of factor Xa to bind directly with factor Xa inhibitors. It is administered intravenously. The FDA approved Andexxa in May 2018 for use in patients being treated with Xarelto and Eliquis, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. The FDA granted Andexxa an accelerated approval for this indication, based on the change from baseline in anti-factor Xa activity in healthy volunteers. Continued approval may be contingent upon the results of FDA mandated postmarket studies to demonstrate an improvement in hemostasis in patients.
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