Well-designed studies comparing the efficacy and safety of andexanet alfa to other reversal strategies are required to confirm preliminary data. The results of the clinical phase III trial ANNEXA as well as current limitations related to andexanet alfa are also discussed.Įxpert opinion: Although phase I and II studies have proven that andexanet alfa can be effective in reversing the effect of factor Xa inhibitors, its efficacy in major bleeding patients has only been shown for apixaban and rivaroxaban, without any comparator group. On 28 of February 2019, the Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a conditional marketing authorization for andexanet alfa in Europe.Īrea covered: The authors provide an overview of andexanet alfa development and its pharmacokinetic and pharmacodynamic properties.
Since May 2018, the FDA has approved its utilization in patients treated with apixaban and rivaroxaban in case of life-threatening or uncontrolled bleeding. Introduction: Andexanet alfa is a recombinant modified factor Xa protein that has been developed to reverse factor Xa inhibitors.
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