The company’s submission of antibody cocktail is based on safety and efficacy data from the Phase 3 PROVENT and STORM CHASER trials
AstraZeneca seeks FDA EUA for AZD7442. (Credit: Jürgen Jester from Pixabay.)
AstraZeneca has filed an application with the US Food and Drug Administration (FDA) seeking emergency use authorisation (EUA) for AZD7442, its antibody cocktail against Covid-19.
AZD7442 is a combination of two long-acting antibodies (LAABs), tixagevimab and cilgavimab, derived from B-cells donated by convalescent patients after Covid-19 infection.
Vanderbilt University Medical Centre discovered the AZD7442 and licensed it to AstraZeneca in June last year.
The British drugmaker optimised the antibody cocktail using its YTE half-life extension technology to enhance its durability three-fold.
AstraZeneca claimed that if authorised, its AZD7442 will be the first LAAB to receive FDA EUA for the prevention of symptomatic Covid-19.
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.”
According to the preliminary in-vitro data, the antibody combination showed anti-Covid activity, including recent emergent SARS-CoV-2 viral variants Delta and Mu.
In Phase 3 trials, AZD7442 showed a significant reduction in the risk of developing symptomatic Covid-19 compared to placebo.
AstraZeneca’s filing is based on safety and efficacy data from the Phase 3 PROVENT and STORM CHASER trials.
In Phase 3 PROVENT trial, AZD7442 reduced the risk of developing symptomatic Covid-19 by 77%, compared to placebo.
Also, it was well-tolerated in the trial population, which comprised people with co-morbidities, who may require additional protection from SARS-CoV-2 infection.
The company is currently in talks with the US Government, along with the governments of other countries around the world, regarding supply agreements for AZD7442.
AstraZeneca is developing AZD7442 with support from the US government, including federal funds from the Department of Health and Human Services (HHS), and BARDA.