Pradaxa Reversal Agent Praxbind Receives Full FDA Approval

Drug is first and only approved specific reversal agent for a novel oral anticoagulant

The FDA has provided full approval for idarucizumab (Praxbind, Boehringer Ingelheim), the specific reversal agent for dabigatran (Pradaxa, Boehringer Ingelheim). Idarucizumab is indicated for patients treated with dabigatran 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 idarucizumab in October 2015, with continued approval contingent upon results from the phase 3 RE-VERSE AD trial. The final results of RE-VERSE AD were published in the New England Journal of Medicine in July 2017 and showed that idarucizumab immediately reversed the anticoagulant effect of dabigatran. The majority of patients had complete reversal of anticoagulation within four hours as measured by ecarin clotting time (82%) or diluted thrombin time (99%).

In the RE-VERSE AD study, no adverse safety signals were observed, and there was a low rate of thrombotic events. In clinical studies, idarucizumab has not shown a procoagulant effect. Health care providers should consider resuming anticoagulant therapy as soon as medically appropriate due to the risk of thrombosis associated with patients’ underlying conditions.

The study, which began in May 2014, is the largest study to investigate a reversal agent for a novel oral anticoagulant in real-world emergency settings. It enrolled a total of 503 patients at 173 sites in 39 countries.

Source: Boehringer Ingelheim; April 17, 2018.