Key result
Andexanet alfa significantly reduced anti-factor Xa activity from baseline to nadir by 94% compared to 21% with placebo in healthy volunteers treated with apixaban.
Absolute Event Rate: 94% vs 21%
p-value: p=<0.001
Andexanet alfa is the first approved universal antidote to reverse the anticoagulant effects of direct or indirect factor Xa inhibitors like rivaroxaban and apixaban.
First approved reversal agent for rivaroxaban/apixaban bleeds; leaves open optimal dosing, safety, and real-world outcomes.
] is a first-in-class recombinant modified factor Xa protein that has been developed by Portola Pharmaceuticals as a universal antidote to reverse anticoagulant effects of direct or indirect factor Xa inhibitors. In May 2018, andexanet alfa received its first global approval in the USA for use in patients treated with rivaroxaban and apixaban, when reversal of anticoagulant effects is required in life-threatening or uncontrolled bleeding. Intravenous andexanet alfa is under regulatory review in the EU and is undergoing clinical development in Japan. This article summarizes the milestones in the development of andexanet alfa leading to this first global approval for reversing anticoagulation of rivaroxaban and apixaban in adults.
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Young‐A Heo (2018) conducted a review in Life-threatening or uncontrolled bleeding in patients treated with factor Xa inhibitors. Andexanet alfa vs. Placebo was evaluated on Reduction in anti-factor Xa activity from baseline to nadir (ANNEXA-A part 1) (p=<0.001). Andexanet alfa significantly reduced anti-factor Xa activity from baseline to nadir by 94% compared to 21% with placebo in healthy volunteers treated with apixaban.