On 4 November 2021 the Therapeutic Goods Administration (TGA) granted provisional determination to AstraZeneca Pty Ltd in relation to the COVID-19 treatment tixagevimab and cilgavimab (EVUSHELD).
This treatment consists of two monoclonal antibodies, tixagevimab and cilgavimab. These antibodies have been developed to bind to the spike protein of the SARS-CoV-2 virus at two different sites. By attaching to the spike protein, the medicine is expected to stop the virus from entering the body's cells and causing infection. This treatment is now eligible to be considered by the TGA for the prevention of COVID-19 in adults aged 18 years and older.
The granting of a provisional determination means that the TGA has made a decision that AstraZeneca Pty Ltd is now eligible to apply for provisional registration for EVUSHELD in the Australian Register of Therapeutic Goods (ARTG). Provisional determination is the first step in the process. It is anticipated that AstraZeneca Pty Ltd will submit an application for provisional registration shortly.
EVUSHELD is not intended to be used as a substitute for vaccination against COVID-19.
In making its decision to grant AstraZeneca Pty Ltd a provisional determination, the TGA considered eligibility criteria, including factors such as evidence of a plan to submit comprehensive clinical data, and the seriousness of the current COVID-19 pandemic.
