Andexanet Alfa for reversal of anticlotting effectsJuly 16, 2018
Andexanet alfa (Andexxa) has been granted approval by the USFDA as an agent for reversing the anticoagulant effects of Factor Xa inhibitors.
Andexanet alfa is the first antidote indicated for the patients treated with rivaroxaban (Xarelto) and apixaban (Eliquis), the inhibitors of Factor Xa, announced by Andexxa’s manufacturer Portola Pharmaceuticals.
Andexanet’s approval is supported by data from two Phase 3 ANNEXA studies published in The New England Journal of Medicine, which evaluated the safety and efficacy of Andexxa in reversing the anticoagulant activity of the Factor Xa inhibitors rivaroxaban and apixaban in healthy volunteers. Results demonstrated that Andexxa rapidly and significantly reversed anti-Factor Xa activity.