AZD7442 Request for Emergency Use Authorization for COVID-19 Prophylaxis Filed in US
Filing includes data from PROVENT Phase III trial showing 77% reduction in risk of developing symptomatic COVID-19 with long-acting antibody combination (non-vaccine)
Potential to provide protection for those not expected to mount an adequate immune response following vaccination
If granted, AZD7442 would be the first LAAB to receive an EUA for COVID-19 prevention. It is the first LAAB with Phase III data demonstrating a statistically significant reduction in the risk of developing symptomatic COVID-19 compared to placebo.
The EUA request filing includes safety and efficacy data from the PROVENT and STORM CHASER Phase III trials and the Phase I trial.
AZD7442 was optimized using AstraZeneca’s proprietary YTE half-life extension technology which more than triples the durability of its action compared to conventional antibodies.1-4
Preliminary ‘in vitro’ findings demonstrate that AZD7442 demonstrates broad anti-COVID activity, and in particular neutralizes recent emergent SARS-CoV-2 viral variants, including the Delta and Mu variants.5,6
Discussions regarding supply agreements for AZD7442 are ongoing with the US government as well as other governments around the world.
AZD7442 is a combination of two LAABs - tixagevimab (AZD8895) and cilgavimab (AZD1061) - derived from B-cells donated by convalescent patients after SARS-CoV-2 virus. Discovered by
AZD7442 is being studied in a comprehensive clinical trial program for both prevention and treatment of COVID-19 in over 9,000 participants. In the Phase III PROVENT trial, AZD7442 reduced the risk of developing symptomatic COVID-19 by 77%, compared to placebo. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The primary analysis was based on 5,172 participants who did not have SARS-CoV-2 infection at baseline. The LAAB was well tolerated and preliminary analyses show adverse events were balanced between the placebo and AZD7442 groups.
Other ongoing trials include TACKLE COVID-19,10 a Phase III mild-to-moderate COVID-19 outpatient treatment trial, and collaborator treatment trials in outpatient and hospitalized settings.
AZD7442 is being developed with support from the US government, including federal funds from the
Data published in Nature in
Under the terms of the licensing agreement with Vanderbilt,
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Jul 1. doi: 10.1126/science.abh1766.
National Center for Advancing Translational Sciences OpenData Portal. SARS-CoV-2 Variants & Therapeutics, All Variants Reported in vitro Therapeutic Activity. Available at: https://opendata.ncats.nih.gov/variant/activity [Last accessed: September 2021].
- Dong J, et al. Genetic and structural basis for recognition of SARS-CoV-2 spike protein by a two-antibody cocktail. bioRxiv. 2021; doi: 10.1101/2021.01.27.428529.
- Loo Y-M, et al. AZD7442 demonstrates prophylactic and therapeutic efficacy in non-human primates and extended half-life in humans. medRxiv.
Cold Spring Harbor Laboratory Press; 2021 [preprint] Available from: https://www.medrxiv.org/content/10.1101/2021.08.30.21262666v1.
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- /NCT04723394. [Last accessed:
30 June 2021].
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