Posted by Michael Wonder on 06 May 2018
U.S. FDA approves Portola Pharmaceuticals’ Andexxa, first and only antidote for the reversal of factor Xa inhibitors
3 May 2018 - Breakthrough product is a major advance in the treatment of patients hospitalised with life-threatening bleeding.
Portola Pharmaceuticals today announced that the U.S. FDA has approved Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anti-coagulation is needed due to life-threatening or uncontrolled bleeding.
The approval of Andexxa is supported by data from two Phase 3 ANNEXA studies (ANNEXA-R and ANNEXA-A) 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. As described in the label, results demonstrated that Andexxa rapidly and significantly reversed anti-factor Xa activity (the anticoagulant mechanism of these medicines). The median decrease in anti-Factor Xa activity from baseline was 97% for rivaroxaban and 92% for apixaban.
