Andexanet Alfa meets endpoints

  • The second part of a Phase 3 study, called ANNEXA-A, evaluating Portola Pharmaceuticals’ (PTLA +2%) andexanet alfa for the sustained reversal of anticoagulation activity of Eliquis (apixaban), met all primary and secondary endpoints with high statistical significance. The trial assessed the safety and effectiveness of a continuous two-hour intravenous infusion of andexanet alfa in healthy volunteers ages 50 – 75 years.
  • Orphan Drug-designated andexanet alfa produced a rapid reversal of the anticoagulation effect of Eliquis as measured by anti-Factor Xa activity, which was sustained for the duration of the infusion.
  • Portola plans to submit a Biologics License Application (BLA) under an Accelerated Approval pathway by the end of the year.