Abstract
Intravenous andexanet alfa [coagulation factor Xa (recombinant), inactivated-zhzo; Andexxa®] 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.
MeSH terms
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Anticoagulants / administration & dosage
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Anticoagulants / adverse effects
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Anticoagulants / pharmacokinetics
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Anticoagulants / therapeutic use*
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Antidotes / pharmacology
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Blood Coagulation / drug effects
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Dose-Response Relationship, Drug
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Drug Approval
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Drug Therapy, Combination
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Factor Xa / administration & dosage
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Factor Xa / adverse effects
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Factor Xa / pharmacokinetics
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Factor Xa / therapeutic use*
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Factor Xa Inhibitors / therapeutic use
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Hemorrhage / drug therapy*
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Humans
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Pyrazoles / therapeutic use
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Pyridones / therapeutic use
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Recombinant Proteins / administration & dosage
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Recombinant Proteins / adverse effects
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Recombinant Proteins / pharmacokinetics
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Recombinant Proteins / therapeutic use*
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Rivaroxaban / therapeutic use
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Treatment Outcome
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United States
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United States Food and Drug Administration
Substances
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Anticoagulants
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Antidotes
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Factor Xa Inhibitors
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PRT064445
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Pyrazoles
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Pyridones
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Recombinant Proteins
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apixaban
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Rivaroxaban
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Factor Xa