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Andexanet alfa for the reversal of factor Xa inhibitors.

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Favresse, Julien [UNamur] Hardy, Michaël [UCL] van Dievoet, Marie-Astrid [UCL] Sennesael, Anne-Laure [UCL] Douxfils, Jonathan [UNamur] Vornicu, Ovidiu [UCL] Dincq, Anne-Sophie [UCL] Lessire, Sarah [UCL] Mullier, François [UCL]

Andexanet alfa is a recombinant modified factor Xa protein that has been developed to reverse factor Xa inhibitors. Since May 2018, the FDA has approved its utilization in patients treated with apixaban and rivaroxaban in case of life-threatening or uncontrolled bleeding. 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. Area covered: The authors provide an overview of andexanet alfa development and its pharmacokinetic and pharmacodynamic properties. The results of the clinical phase III trial ANNEXA as well as current limitations related to andexanet alfa are also discussed. Expert 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. Well-designed studies comparing the efficacy and safety of andexanet alfa to other reversal strategies are required to confirm preliminary data. The benefit of andexanet alfa in specific settings needs to be investigated and its use in clinical practice needs to be facilitated by the implementation of international guidelines.

Document type Article de périodique (Journal article) – Synthèse de littérature
Access type Accès libre
Publication date 2019
Language Anglais
Journal information "Expert opinion on biological therapy" - Vol. 19, no. 5, p. 387-397 (2019)
Peer reviewed yes
Publisher Taylor & Francis ((United Kingdom) Abingdon)
issn 1471-2598
e-issn 1744-7682
Publication status Publié
Affiliations UCL - SSS/IREC/MONT - Pôle Mont Godinne
UCL - SSS/IREC/MEDA - Pôle de médecine aiguë
UCL - (MGD) Service d'anesthésiologie
UCL - (MGD) Laboratoire de biologie clinique
UCL - (SLuc) Service de biochimie médicale
UCL - (SLuc) Service de biologie hématologique
UCL - SSS/LDRI - Louvain Drug Research Institute
Keywords ANNEXA ; Andexanet alfa ; DOACs ; antidote ; factor Xa ; major bleeding ; reversal agents
Links
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