AstraZeneca Submits New Drug Application in China for Andexanet Alfa, a Specific Reversal Agent for Factor Xa Inhibitors

On December 16, the CDE website showed that the marketing application of andexanet alfa was accepted by the NMPA. This product can be used to reverse the anticoagulant effect of factor Xa inhibitors.

Andexanet alfa is a modified human coagulation factor Xa (FXa) protein specifically designed to bind to FXa inhibitors and rapidly reverse their anticoagulant effects. It can prevent the binding of natural FXa to FXa inhibitors, thereby restoring normal hemostasis.

Andexanet alfa 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. This product is the first and only antidote for rivaroxaban and apixaban.

In June this year, a Phase IV post-marketing ANNEXA-I study was terminated early due to the pre-established criteria for hemostatic superiority being met in advance. The study aimed to evaluate the efficacy and safety of andexanet alfa in patients receiving oral FXa inhibitor therapy (including apixaban and rivaroxaban) who experienced 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 showed that the reversal effect of andexanet alfa occurred earlier than initially anticipated. AstraZeneca stated it will terminate the ANNEXA-I study and proceed with regulatory submissions in the United States and the European Union to seek full approval for andexanet alfa.

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