AstraZeneca seeks USFDA authorization for Covid-19 Prophylaxis drug AZD7442

In August, 2021, AstraZeneca announced high-level results from the PROVENT pre-exposure prophylaxis trial which showed AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% (95% confidence interval (CI): 46, 90), compared to placebo. Importantly, the trial population included people with co-morbidities and who may be in need of additional protection from SARS-CoV-2 infection. Greater than 75% of participants in PROVENT presented with co-morbidities associated with an increased risk of severe disease or a reduced immune response to vaccination. The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis. AZD7442 was well-tolerated.

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 optimised using AstraZeneca's proprietary YTE half-life extension technology which more than triples the durability of its action compared to conventional antibodies.

Preliminary 'in vitro' findings demonstrate that AZD7442 demonstrates broad anti-COVID activity, and in particular neutralises recent emergent SARS-CoV-2 viral variants, including the Delta and Mu variants.

"Discussions regarding supply agreements for AZD7442 are ongoing with the US Government as well as other governments around the world," the company said.