Posted by Michael Wonder on 18 Apr 2018
FDA provides full approval to Praxbind, specific reversal agent for Pradaxa
17 April 2018 - Decision converts Praxbind’s (idarucizumab) accelerated approval, granted in October 2015, to full approval.
Boehringer Ingelheim today announced that the U.S. FDA has provided full approval for Praxbind (idarucizumab), the specific reversal agent for Pradaxa (dabigatran etexilate mesylate). Praxbind is indicated for patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.
The FDA granted accelerated approval to Praxbind in October 2015, with continued approval contingent upon results from the phase III RE-VERSE AD trial, the largest study to investigate a reversal agent for a NOAC. The final results of RE-VERSE AD were published in the New England Journal of Medicine in July 2017, and showed that Praxbind immediately reversed the anticoagulant effect of Pradaxa. The majority of patients had complete reversal of anticoagulation within four hours as measured by ecarin clotting time (ECT 82%) or diluted thrombin time (dTT 99%).
