AstraZeneca Halts Phase IV ANNEXA-I Trial Early Due to Superior Efficacy of Andexxa in Reversing Life-Threatening Bleeding

On June 5, AstraZeneca announced that the ANNEXA-I trial was terminated early due to the pre-specified hemostatic superiority criteria being met. ANNEXA-I is a Phase IV post-marketing trial designed to evaluate the efficacy and safety of Andexxa (andexanet alfa) in patients receiving oral FXa inhibitor therapy (including apixaban and rivaroxaban) who experience life-threatening or uncontrolled bleeding requiring reversal of anticoagulation.

The recommendation to halt the trial was made by the independent Data and Safety Monitoring Board (DSMB). Following randomization of 450 patients and one month of follow-up, a pre-planned interim efficacy analysis was conducted, revealing that Andexxa’s reversal effect occurred earlier than initially anticipated.

Andexxa (andexanet) is a recombinant protein specifically designed to bind to FXa inhibitors and rapidly reverse their anticoagulant effects. Andexanet is a modified human coagulation factor Xa (FXa) protein that can impede the binding of native FXa to FXa inhibitors, thereby restoring normal hemostasis.

Andexxa has received accelerated approval in the United States and conditional approval in the European Union, Switzerland, and the United Kingdom for patients treated with the FXa inhibitors apixaban and rivaroxaban who experience life-threatening or uncontrolled bleeding requiring reversal of anticoagulation. The use of Andexxa is supported by more than 15 national and international guidelines.

AstraZeneca stated that it will terminate the ANNEXA-I study and continue regulatory submissions in the United States and the European Union to seek full approval for Andexxa. Complete efficacy and safety results will be presented at upcoming medical conferences and publications.

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