We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
Andexxa
Published
Product name
Andexxa
Active ingredient
Andexanet alfa
Submission type
New Biological Entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Andexxa (andexanet alfa) was provisionally approved for the following therapeutic use:
Andexxa (andexanet alfa) has provisional approval in Australia for adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
The decision to approve this indication has been made on the basis of haemostatic efficacy and reduction in anti-FXa activity. Continued approval of this indication depends on verification and description of benefit in a confirmatory trial.
How this medicine works
Andexanet alfa is a recombinant form of human Factor Xa (FXa) protein that has been modified to lack FXa enzymatic activity. The active site serine was substituted with alanine, rendering the molecule unable to cleave and activate prothrombin, and the gamma-carboxyglutamic acid (Gla) domain was removed to eliminate the ability of the protein to assemble into the prothrombinase complex, thus removing any anti-coagulant effects.
Andexanet alfa is a specific reversal agent for FXa inhibitors. The predominant mechanism of action is the binding and sequestration of the FXa inhibitor. In addition, andexanet alfa has been observed to bind to, and inhibit tissue factor pathway inhibitor (TFPI). Inhibition of TFPI activity can increase tissue factor-initiated thrombin generation inducing a pro-coagulant effect.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Andexxa was considered favourable for the therapeutic use approved.
Sponsor