Food and Drug Administration granted accelerated approval to Portola Pharmaceuticals’ Andexxa (andexanet alfa), the first in its class. 4 Only Pradaxa (dabigatran), a direct thrombin inhibitor, had a reversal agent, Praxbind (idarucizumab), approved in 2015. Kcentra, an agent that is indicated for reversal of vitamin K antagonists (e.g., warfarin), has been used in the clinical setting for factor Xa-associated bleeding, but this agent is not a direct antidote. 3 Apixaban and rivaroxaban are highly protein-bound and cannot be eliminated through dialysis. 1, 2 This was a cause for concern since there is an estimated 117,000 hospital admissions and 2,000 deaths per month due to factor Xa inhibitor-associated bleeding in the United States alone. While apixaban and rivaroxaban have been available since 20, respectively, there had been no approved reversal agent. Eliquis (apixaban) and Xarelto (rivaroxaban) are two of the most commonly prescribed factor Xa inhibitors, with an estimated 4 million patients currently taking them for risk reduction of stroke and systemic embolism in nonvalvular atrial fibrillation, prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism (PE) after hip or knee surgery, and treatment and prophylaxis of DVT and PE.

Andexxa trial