Portola Pharmaceuticals have completed the submission of a Biologics License Application (BLA) for its investigational agent andexanet alfa, to the US Food and Drug Administration (FDA). Andexanet alfa therapy is designed to reverse the anticoagulant activity of both direct and indirect Factor Xa inhibitors.
Andexanet alfa is being developed as a universal reversal agent for patients who are anticoagulated with an oral or injectable Factore Xa inhibitor, and who experience a serious uncontrolled bleeding event or who require emergency surgery.
The BLA submission includes data from Portola’s Phase 3 ANNEXATM (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of FXa Inhibitors) studies, which evaluated the safety and efficacy of andexanet alfa in reversing the anticoagulant activity of the Factor Xa inhibitors rivaroxaban and apixaban, respectively, in healthy volunteers. Results of those studies were published online by The New England Journal of Medicine in November 2015. In addition, data from a small number of patients from ANNEXA-4 will serve as the clinical basis for the BLA. Portola is currently evaluating andexanet alfa in this global Phase 4 single-arm, open-label confirmatory study in patients receiving apixaban, rivaroxaban, edoxaban or enoxaparin (a low molecular weight heparin and indirect Factor Xa inhibitor) who present with an acute major bleed.