THE Therapeutic Goods Administration (TGA) has granted a provisional determination to AstraZenca for its COVID-19 treatment, Evusheld (tixagevimab and cilgavimab), for use in adolescents and adults aged 12 years and older.
The move follows an initial determination for the prevention of COVID-19 in adults aged 18 years and older issued on 01 Nov 2021.
"This treatment consists of two monoclonal antibodies, tixagevimab and cilgavimab," the TGA said.
"These antibodies 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.
"The granting of a provisional determination means that the TGA has made a decision that AstraZeneca is now eligible to apply for provisional registration for Evusheld in the Australian Register of Therapeutic Goods (ARTG) in this age group.
"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."
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