Hours before its PDUFA date, Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo] won accelerated approval from the FDA as the first antidote designed for use with rivaroxaban (Xarelto, Janssen Pharmaceuticals Inc.) and apixaban (Eliquis, Pfizer Inc./Bristol-Myers Squibb Co.) to reverse anticoagulation during life-threatening or uncontrolled bleeding. With its orphan drug and breakthrough therapy designations, Andexxa was approved based on change from baseline in anti-factor Xa activity in healthy volunteers.