TGA approves AstraZeneca's COVID-19 preventative treatment

The Therapeutic Goods Administration (TGA) has granted provisional approval to AstraZeneca for its tixagevimab and cilgavimab (EVUSHELD) combination therapy for the prevention of COVID-19 in people who are at risk of infection but have not been exposed to the virus.

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.

The treatment 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, the TGA noted.

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.

The Australian Government has secured 36,000 treatment courses of EVUSHELD from AstraZeneca. The treatment has also received Emergency Use Authorization from the United States Food and Drug Administration (FDA).

Image credit: ©stock.adobe.com/au/ThamKC

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