AstraZeneca Files EUA for the First COVID-19 Antibody Prophylaxis

AstraZeneca’s long-acting antibody, AZD7442, would act as a supplement to vaccination and could provide up to a year of protection against symptomatic COVID-19.

AstraZeneca submitted a Food and Drug Administration (FDA) request today for an Emergency Use Authorization (EUA) for AZD7442, its long-acting antibody (LAAB) combination.

If approved, AZD7442 would become the first drug to provide pre-exposure prophylaxis for symptomatic COVID-19.

AZD7442 is already the first LAAB with phase 3 data showing a statistically significant reduction in the risk of developing symptomatic COVID-19.

AZD7442 is intended to supplement a COVID-19 vaccination to further protect vulnerable populations from contracting severe, symptomatic COVID-19.

The PROVENT trial conducted in August showed high-level results for the pre-exposure prophylaxis AZD7442, which reduced the risk of symptomatic COVID-19 by 77% (95% confidence interval (CI): 46, 90) as compared to a placebo.

The trial population intentionally included a majority (>75%) of people with comorbidities, who would be among those most in need of additional COVID-19 protection. There were 25 cases of symptomatic COVID-19 throughout the trial. Additionally, AZD7442 was well-tolerated by the trial participants.

AstraZeneca formulated AZD7442 with their YTE half-life extension technology, which promises to more than triple the drug’s durability compared to conventional antibodies. The half-life extension could provide up to 12 months of COVID-19 protection after a single dose.

Preliminary in vitro findings show that AZD7442 demonstrates broad anti-COVID activity, and in particular neutralizes recent emergent COVID-19 viral variants, including the Delta and Mu variants.

AZD7442 is a combination of the tixagevimab (AZD8895) and cilgavimab (AZD1061) LAABs, derived from B-cells donated by patients recovering from COVID-19.

Vanderbilt University Medical Center discovered the human monoclonal antibodies that bind to distinct sites on the COVID-19 spike protein, and AstraZeneca licensed the technology in June 2020, before optimizing it with half-life extension, reduced Fc receptor, and complement C1q binding.

AZD7442 is being developed with the support of the US and other governments worldwide are in conversation with AstraZeneca to negotiate supply agreements for AZD7442.