In the Phase 3 Provent trial, Evusheld (AZD442) cut the risk of developing symptomatic COVID-19 by 77% in the primary analysis focused on patients at high risk for severe COVID-19. The monoclonal antibody cocktail, including tixagevimab and cilgavimab cut the risk by 83% in the six-month follow-up analysis compared to placebo.
The drug is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19.
Evusheld won a EUA in December 2021.
The adults enrolled in the trial had an inadequate response to COVID-19 vaccination, an elevated risk of exposure to SARS-CoV-2 or both. Subjects were either obese, immunocompromised, had pre-existing health conditions such as heart failure or chronic kidney disease, or were 60 years of age or older.
After receiving a single 300 mg intramuscular dose of Evusheld, concentrations of the drug remained elevated for six months after administration, according to a pharmacokinetic analysis.
The research was summarized in the New England Journal of Medicine.
“While COVID-19 vaccines have been highly effective at reducing hospitalization and death, cases continue to surge, and many individuals remain at high risk, including immunocompromised individuals and those who cannot be vaccinated,” said Dr. Myron J. Levin, principal investigator of the Provent study.
Data indicate that Evusheld remains effective against the omicron variant, including BA.2.
Filed Under: clinical trials, Drug Discovery, Infectious Disease
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