TGA provisionally approves AstraZeneca's combination therapy (tixagevimab and cilgavimab, EVUSHELD) - for pre-exposure prevention (prophylaxis) of COVID-19

On 24 February 2022 the Therapeutic Goods Administration (TGA) granted provisional approval to AstraZeneca Pty Ltd for its tixagevimab and cilgavimab (EVUSHELD) for the prevention of COVID-19 in people who are at risk of infection but have not been exposed to the virus, known as pre-exposure prevention of COVID-19.

EVUSHELD has been granted provisional approval for the pre-exposure prophylaxis (prevention) of COVID-19 in people aged 12 years and older weighing at least 40 kg:

• who have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments that make it likely that they will not mount an adequate immune response to COVID-19 vaccination; or
• for whom vaccination is not recommended due to a history of severe adverse reaction to a COVID‐19 vaccine or COVID‐19 vaccine component.

Pre-exposure prevention with EVUSHELD is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended.

EVUSHELD is administered as two separate, sequential injections of two long-acting monoclonal antibodies, tixagevimab and cilgavimab. These antibodies bind to the spike protein of the SARS-CoV-2 virus at two different sites to stop the virus from entering the body's cells and causing infection.

In making this regulatory decision, the TGA carefully considered data from the PROVENT Phase III pre-exposure prevention trial. The study demonstrated that EVUSHELD significantly reduces the risk of developing symptomatic COVID-19 with protection from the virus continuing for at least six months.

Provisional approval of EVUSHELD is subject to certain strict conditions, such as the requirement for the sponsors to continue providing information to the TGA on longer-term efficacy and safety from ongoing clinical trials and post-market assessment. The decision was informed by expert advice from the Advisory Committee on Medicines, an independent committee with expertise in scientific, medical and clinical fields as well as consumer representation.

EVUSHELD has also received Emergency Use Authorizations from the United States Food and Drug Administration (US FDA).

The Australian Government has secured 36,000 treatment courses of EVUSHELD from AstraZeneca Pty Ltd.

Contact for members of the media:

• Email: news@health.gov.au
• Phone: 02 6289 7400