Any expanded Food and Drug Administration indication will be contingent on results demonstrating improved hemostasis and efficacy for reversing other FXa inhibitors.Īndexanet alfa Anticoagulation reversibility Direct oral anticoagulants Factor Xa inhibitors.Ĭopyright © 2019. This indication is approved under accelerated approval based on the change from baseline in anti-human Factor Xa activity in healthy volunteers.
This accelerated approval was based on change in anti-FXa activity from baseline that indicated a reversal of the anticoagulant effect. ANDEXXA is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed, due to life-threatening or uncontrolled bleeding. Andexanet alfa was approved in May 2018, under the brand name ANDEXXA, for the reversal of 2 of FXa inhibitors, apixaban and rivaroxaban, when life-threatening or uncontrolled bleeding occurs. Food and Drug Administration approved idarucizumab (Praxbind) for the reversal of the direct thrombin inhibitor dabigatran, but no reversal agent has been available for oral factor Xa (FXa) inhibitors until recently. The use of direct oral anticoagulants over traditional warfarin has increased in the United States over the past 10 years because of advantages such as ease of use, predictable pharmacokinetic response, and safety.
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