The Antidote Is Finally Here! Idarucizumab, A Specific Reversal Agent for the Anticoagulant Effects of Dabigatran.

Despite the availability, safety, and efficacy of novel oral anticoagulants (NOACs) compared with warfarin, acceptance and use have been hampered by lack of a specific reversal agent. Thismay be part of the reasonwhy anticoagulants remainwidely underprescribed for stroke prevention in atrial fibrillation. The lack of an antidote to reverse NOACs in emergent situations such as lifethreatening bleeding or emergentmajor surgery has been a significant clinical issue until now. The recent approval of idarucizumab (Praxbind; Boehringer Ingelheim, Ridgefield, Connecticut) to reverse the anticoagulant effects of dabigatran (Pradaxa; Boehringer Ingelheim) has resulted in the first and only NOAC with a specific reversal agent. Pradaxa was approved in 2010 to prevent stroke and systemic blood clots in patients with atrial fibrillation and for the treatment and prevention of deep venous thrombosis and pulmonary embolism without a specific reversal agent. Now, Praxbind has been approved specifically for Pradaxa under the FDA’s accelerated approval program (http://www.fda.gov/ForPatients/Approvals/Fast/ucm405447 .htm), which permits drug approval for serious conditions that is likely to provide a clinical benefit.