Lapse of provisional registration for Andexxa (andexanet alfa) used for Factor Xa inhibitor (apixaban/rivaroxaban) reversal

On 20 May 2026, the provisional registration of AstraZeneca Pty Ltd’s ANDEXXA (andexanet alfa) lapsed. This means ANDEXXA is no longer provisionally approved for use in Australia and has been removed from the Australian Register of Therapeutic Goods (ARTG).

ANDEXXA was provisionally approved in Australia on 3 July 2023 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 provisionally approve ANDEXXA was based on the following information submitted by the sponsor, AstraZeneca:

• full quality data, including chemistry and manufacturing
• nonclinical data, including pharmacology and toxicology
• preliminary clinical data, including pharmacology, safety and efficacy, and 
• a risk management plan. 

ANDEXXA was provisionally registered based on early clinical evidence of benefit in a high‑risk setting, allowing earlier access while further data were to be generated. Additional clinical evidence is still needed to support full registration. The provisional registration period is limited to a maximum of 6 years. Extension of provisional registration requires that there is a plan for confirmatory clinical data to be generated and provided. The sponsor has advised it is unable to complete the required confirmatory trials within the legislated timeframe, and has therefore chosen not to pursue full registration in Australia.

The Therapeutic Goods Administration (TGA) and AstraZeneca are working to agreed timeframes. This will include coordinated communications to relevant stakeholders such as healthcare professionals and hospitals, and the withdrawal of the sponsor’s current application. 

A summary of the application, including advice from the Advisory Committee on Medicines, is available in the Australian Public Assessment Report for ANDEXXA. A discontinuation notification has been published on the Medicine shortage reports database. 

Information for consumers

• The available evidence was not sufficient to confirm the benefits of ANDEXXA outweigh the risks to support full registration.
• AstraZeneca is communicating directly with wholesalers and health care professionals. 
• The TGA strongly encourages patients to speak to their doctor about the above, including to discuss future treatment options.

AstraZeneca can be contacted via its Medical information team for further information on: 
1800 805 342 or AstraZeneca Medical Website. Or email Medical Information enquiries to medinfo.australia@astrazeneca.com.

Provisional registration

The provisional pathway provides a formal and transparent mechanism for speeding up the registration of promising new medicines, or new uses of existing medications, with preliminary clinical data. The decision to provisionally register a medicine means that the TGA has assessed that the benefit of early availability outweighs the risk that additional data are still required.

Provisional registration is limited to a maximum of 6 years. Sponsors may apply for full registration once they believe sufficient clinical data are available to confirm the safety and efficacy of the medicine/new use. However, if sufficient data can’t be supplied, then the provisional registration will lapse at the end of the specified period.

Further information on the Apply for a prescription medicine via the provisional registration pathway page.