AstraZeneca has submitted a request seeking the US Food and Drug Administration’s (FDA) emergency use authorization (EUA) for its long-acting antibody (LAAB) combination, AZD7442, to prevent symptomatic Covid-19.
Discovered by Vanderbilt University Medical Center, AZD7442 is a combination of tixagevimab (AZD8895) and cilgavimab (AZD1061).
In June last year, it was licenced to AstraZeneca.
The request filing made for the EUA includes data from the PROVENT Phase III pre-exposure prophylaxis trial which included 5,197 participants in a 2:1 randomisation AZD7442 to placebo.
It showed a 77% reduction in risk of developing symptomatic Covid-19 using AZD7442.
According to the preliminary ‘in vitro’ findings, the long-acting antibody combination demonstrated broad anti-Covid activity and neutralised SARS-CoV-2 viral variants, including the Delta and Mu that emerged recently.
Subjects with co-morbidities and in need of additional protection from SARS-CoV-2 infection were included in the trial.
The EUA request filing also includes safety and efficacy data from the STORM CHASER Phase III trials and the Phase I trial.
AstraZeneca stated that its YTE half-life extension technology, which triples its strength when compared to conventional antibodies, was used to optimise AZD7442.
If the product is approved in the US, it would be the first LAAB to get the EUA for Covid-19 prevention.
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. We look forward to sharing AZD7442 data for the treatment of Covid-19 later this year.”
The company is also carrying out discussions with the US and other governments globally about supply agreements for AZD7442.