Intravenous andexanet alfa [coagulation factor Xa (recombinant), 
inactivated-zhzo; Andexxa®] is a first-in-class recombinant modified factor Xa 
protein that has been developed by Portola Pharmaceuticals as a universal 
antidote to reverse anticoagulant effects of direct or indirect factor Xa 
inhibitors. In May 2018, andexanet alfa received its first global approval in 
the USA for use in patients treated with rivaroxaban and apixaban, when reversal 
of anticoagulant effects is required in life-threatening or uncontrolled 
bleeding. Intravenous andexanet alfa is under regulatory review in the EU and is 
undergoing clinical development in Japan. This article summarizes the milestones 
in the development of andexanet alfa leading to this first global approval for 
reversing anticoagulation of rivaroxaban and apixaban in adults.