Andexanet alfa also will not have to be used that often, but the potential pool of patients is larger than for idarucizumab. Though idarucizumab has not been extensively used since its approval, Connors pointed out that the drug it reverses is not prescribed as frequently as rivaroxaban and apixaban. There was no specific reversal agent for this class of drugs until now.

Jean Connors, MD (Brigham and Women’s Hospital, Boston, MA), told TCTMD the availability of andexanet alfa is critical because other strategies for reversing bleeding in patients treated with the factor Xa inhibitors are only partially effective. The FDA previously declined to approve andexanet alfa in August 2016, citing the need for more information related to manufacturing and more data to support inclusion of all of the factor Xa inhibitors on the label. The only other approved reversal agent for the non-vitamin K antagonist oral anticoagulants (NOACs)- given the FDA’s okay in October 2015 -is idarucizumab (Praxbind), an antidote for the direct thrombin inhibitor dabigatran (Pradaxa both Boehringer Ingelheim). The antidote is indicated for use in patients who bleed while taking either rivaroxaban (Xarelto Bayer/Janssen) or apixaban (Eliquis Bristol-Myers Squibb), but the indication does not cover the other direct factor Xa inhibitors edoxaban (Savaysa Daiichi Sankyo) and betrixaban (Bevyxxa)-which was approved last June for prevention of venous thromboembolism-or enoxaparin, an indirect factor Xa inhibitor. The US Food and Drug Administration (FDA) has cleared andexanet alfa (Andexxa) as a reversal agent for the anticoagulant effects of the two most commonly used factor Xa inhibitors in patients with life-threatening or uncontrolled bleeding, manufacturer Portola Pharmaceuticals announced late yesterday.

Praxbind fda approval