FDA Rejects Eliquis Antidote
If you start bleeding when using one of the new NOAC (New Oral Anti-cogulants).. Isn’t it reassuring that if you start to HEMORRHAGE… 79% of the pts will get excellent/good blood clotting within TWELVE HOURS.. Maybe the other 21% JUST BLEEDS TO DEATH ?
Warfarin has always been the gold standard for venous thromboembolism treatment and stroke/systemic embolism prophylaxis in patients with nonvalvular atrial fibrillation. In the past few years, novel oral anticoagulants (NOACs) like edoxaban (Savaysa), apixaban (Eliquis), rivaroxaban (Xarelto), and dabigatran (Pradaxa) have emerged as alternative treatment because of their favorable pharmacokinetics, pharmacodynamics, and minimal adverse events.
Vitamin K has been the antidote for warfarin for a long time, but the only available antidote for the NOAC class is idarucizumab (Praxbind) for Pradaxa. The lack of other antidotes within the class is worrisome because uncontrollable bleeding can be fatal.
Interim results of the ongoing Phase 3b/4 ANNEXA-4 study demonstrated AndexXa rapidly reversed anticoagulant effects of factor Xa inhibitors, with 79% of patients achieving excellent or good hemostasis over 12 hours. However, the FDA rejected AndexXa and is requiring manufacturer Portola Pharmaceuticals to provide additional information to support the inclusion of 2 other drugs in the antidote’s label: edoxaban and enoxaparin. Portola plans on resubmitting its application by the end of 2016. – See more at: http://www.pharmacytimes.com/contributor/charles-ng-pharmd-mba-candidate-2017/2016/09/5-things-happening-in-the-pharmacy-world-today#sthash.98Q1Dm0Z.dpuf
Vitamin K has been the antidote for warfarin for a long time, but the only available antidote for the NOAC class is idarucizumab (Praxbind) for Pradaxa. The lack of other antidotes within the class is worrisome because uncontrollable bleeding can be fatal.
Interim results of the ongoing Phase 3b/4 ANNEXA-4 study demonstrated AndexXa rapidly reversed anticoagulant effects of factor Xa inhibitors, with 79% of patients achieving excellent or good hemostasis over 12 hours. However, the FDA rejected AndexXa and is requiring manufacturer Portola Pharmaceuticals to provide additional information to support the inclusion of 2 other drugs in the antidote’s label: edoxaban and enoxaparin. Portola plans on resubmitting its application by the end of 2016. – See more at: http://www.pharmacytimes.com/contributor/charles-ng-pharmd-mba-candidate-2017/2016/09/5-things-happening-in-the-pharmacy-world-today#sthash.98Q1Dm0Z.dpuf
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