Andexanet Alfa: First Global Approval

Direct or indirect factor Xa inhibitors are effective anticoagulants for the treatment and prevention of thromboembolism, and stroke prevention in atrial fibrillation

Young-A Heo

2018

Scholarcy highlights

  • Direct or indirect factor Xa inhibitors are effective anticoagulants for the treatment and prevention of thromboembolism, and stroke prevention in atrial fibrillation
  • Intravenous andexanet alfa is a first-in-class recombinant modified factor Xa protein that has been developed by Portola Pharmaceuticals as a universal antidote to reverse the anticoagulant effects of direct or indirect factor Xa inhibitors
  • Andexanet alfa acts as a decoy and binds to factor Xa inhibitors, neutralizing the anticoagulant effects of factor Xa inhibitors by preventing the inhibitors from binding to endogenous factor Xa
  • On 3 May 2018, andexanet alfa received US FDA accelerated approval for patients treated with rivaroxaban or apixaban who require reversal of the anticoagulant effects in life-threatening or uncontrolled bleeding
  • Further supportive evidence for the efficacy of andexanet alfa in reducing anti-factor Xa activity of direct or indirect factor Xa inhibitors is available from several dose-ranging, proof-of-concept phase II studies in healthy volunteers
  • HealthCare Royalty Partners is eligible to receive a tiered mid-single-digit royalty on any potential worldwide sales of andexanet alfa
  • Andexanet alfa received its first global approval on 3 May 2018 in the USA for use in adults treated with rivaroxaban and apixaban, when reversal of its anticoagulant effects is required because of life-threatening or uncontrolled bleeding

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