John Libbey Eurotext



An antidote available for the first DOAC on the market Volume 23, issue 6, Novembre-Décembre 2017


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Centre de référence et d’éducation des antithrombotiques d’Ile-de-France (CREATIF) et IVS, Hôpital Lariboisière, 2 rue Ambroise Paré, 75475 Paris cedex 10, France ; EA 7334 REMES Université Paris VII – Paris Diderot, France
* Tirés à part

For years the only oral anticoagulant available was the vitamin K antagonists (VKA). In recent years progressively appeared direct oral anticoagulants (NOACs) first dabigatran (direct thrombin inhibitor) and then rivaroxaban, apixaban and edoxaban direct inhibitors of Factor Xa. They are characterized by equal or better than VKA efficiency and risk of bleeding in the main clinical setting where they were evaluated: prevention and treatment of venous thromboembolic events and prevention of arterial embolism in particular cerebrovascular in patients affected by non-valvular fibrillation. Nevertheless, the lack of antidote is presented and perceived both by prescribers and patients as a major argument for not taking/prescribing in fear of major bleeding or emergency surgery. Dabigatran is the first NOAC to provide an effective antidote immediately and without side effects. This review will trace the development of this antibody Idarucizumab until the initial results on the first 90 patients of the pivotal Phase 3. This development allowed a fast authorization to get to the market both in the US (FDA) and Europe (EMA).