New Drug Reverses Anticoagulant Effect of Dabigatran

Idarucizumab, an antibody fragment, shows promise in reversing the anticoagulant effect of dabigatran (Pradaxa). Researchers looked at 90 patients who needed reversal of dabigatran because of serious bleeding (n = 51) or needed an urgent procedure (n = 39). The endpoint was the reversal of the anticoagulant effect at 4 hours. In patients with testing validating an anticoagulant effect at baseline, all were reversed at 4 hours (100%; 95% confidence interval, 100 to 100). Idarucizumab normalized test results in 88-98% of patients, and the effect was evident within minutes of administration of the drug. The authors conclude that idarucizumab completely reversed the anticoagulant effect of dabigatran within minutes (published online June 22, 2015.DOI: 10.1056/NEJMoa1502000).

This is a Phase 3 trial for idarucizumab, which is manufactured by Boehringer Ingelheim. The company received a priority review by the FDA, clearing the way for approval later this year. It will be the first reversal agent for any of the new oral anticoagulants, which may give dabigatran a competitor against rival drugs rivaroxaban (Xarelto), apixaban (Eliquis), and edoxaban (Savaysa), which do not have reversal agents.