Andexanet alfa for the reversal of factor Xa inhibitors
| Autor: | Julien Favresse, Michael Hardy, Charles-Marc Samama, A L Sennesael, M A van Dievoet, Ovidiu Ionut Vornicu, Sarah Lessire, Anne-Sophie Dincq, François Mullier, Jonathan Douxfils |
|---|---|
| Přispěvatelé: | 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 |
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
medicine.drug_mechanism_of_action factor Xa medicine.medical_treatment Clinical Biochemistry Factor Xa Inhibitor Hemorrhage Pharmacology law.invention 03 medical and health sciences 0302 clinical medicine law Drug Discovery Factor Xa Inhibitors/immunology medicine Humans In patient Recombinant Proteins/biosynthesis Antidote Clinical Trials as Topic business.industry ANNEXA virus diseases Factor Xa/genetics Andexanet alfa DOACs Recombinant Proteins 030104 developmental biology major bleeding 030220 oncology & carcinogenesis Factor Xa Recombinant DNA reversal agents business Major bleeding antidote Hemorrhage/drug therapy medicine.drug Factor Xa Inhibitors Half-Life |
| Zdroj: | Expert opinion on biological therapy, Vol. 19, no. 5, p. 387-397 (2019) |
| ISSN: | 1744-7682 |
| Popis: | INTRODUCTION: 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. |
| Databáze: | OpenAIRE |
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