Honickel M, Braunschweig T, Ryn JV, et al. In a trauma experimental pig model prothrombin complex concentrates and a specific antidote (idarucizumab) are effective to reverse the anticoagulant effects of dabigatran. Dabigatran-induced anticoagulant and bleeding effects can be reversed with both prothrombin complex concentrates and a specific antidote (idarucizumab) in a lethal porcine polytrauma model. Effects of idarucizumab, given as a split dose, in a blunt liver double trauma model in pigs receiving dabigatran. Honickel M, van Ryn J, Rossaint R, et al.

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Boehringer Ingelheim submits applications for approval of idarucizumab, specific reversal agent to dabigatran etexilate (Pradaxa ®), to EMA, FDA and Health Canada. FDA approves Praxbind ® (idarucizumab), specific reversal agent for Pradaxa ® (dabigatran etexilate mesylate). īoehringer Ingelheim Pharmaceuticals Inc. EMA fast-tracks antidote to anticoagulant Pradaxa. Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: a randomised, placebo-controlled, double-blind phase 1 trial. FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa. FDA grants priority review to Boehringer Ingelheim’s biologics license application for idarucizumab. Boehringer Ingelheim’s investigational antidote for Pradaxa ® (dabigatran etexilate mesylate) receives FDA breakthrough therapy designation. Praxbind ® (idarucizumab) injection, for intravenous use: US prescribing information. Reversal agents in development for the new oral anticoagulants. Managing target-specific oral anticoagulant associated bleeding including an update on pharmacological reversal agents. Pradaxa 110 mg hard capsules: summary of product characteristics.

Pradaxa ® (dabigatran etexilate mesylate) capsules for oral use: US prescribing infomation.

Praxbind fda approval