AZD7442 is a cocktail of two long-acting antibodies — tixagevimab (AZD8895) and cilgavimab (AZD1061).
The US Vanderbilt University Medical Center-discovered LAAB combination was licenced to AstraZeneca in June last year.
It is obtained from B-cells convalescent patients following Covid-19 infection.
If FDA grants EUA, AZD7442 will become the first-ever LAAB to receive such authorisation for Covid-19 prophylaxis, AstraZeneca noted.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “Vulnerable populations such as the immunocompromised often aren’t able to mount a protective response following vaccination and continue to be at risk of developing Covid-19.
“With this first global regulatory filing, we are one step closer to providing an additional option to help protect against Covid-19 alongside vaccines.”
The EUA application comprises safety as well as efficacy results from the Phase III PROVENT and STORM CHASER clinical trials and a Phase I trial.
AZD7442 is the only LAAB with Phase III results showing a statistically significant decline in the risk of symptomatic Covid-19 development versus placebo, AstraZeneca added.
The company had reported data from the PROVENT pre-exposure prophylaxis trial of the antibody cocktail in August this year.
In the trial, AZD7442 offered a 77% decline in the risk of developing the symptomatic disease compared to placebo.
In the PROVENT trial, more than 75% of subjects had co-morbidities linked to a high risk of severe disease or a reduced immune response to vaccines.
Findings showed that 25 symptomatic Covid-19 cases were reported at the initial assessment of the trial while the combination treatment was demonstrated to be well-tolerated.
As per the initial in vitro data, AZD7442 was found to offer wide-ranging anti-Covid activity.
In addition, it also showed to neutralise emerging variants of SARS-CoV-2, such as Delta and Mu variants.
AstraZeneca is holding talks with the US Government and others on distribution agreements for the LAAB combination.