AstraZeneca seeks USFDA authorization for Covid-19 Prophylaxis drug AZD7442
UK: AstraZeneca has submitted a request to the US Food and Drug Administration (USFDA) for an Emergency Use Authorization (EUA) for AZD7442, its long-acting antibody (LAAB) combination, for prophylaxis of symptomatic COVID-19.
If granted, AZD7442 would be the first LAAB to receive an EUA for COVID-19 prevention. It is the first LAAB with Phase III data demonstrating a statistically significant reduction in the risk of developing symptomatic COVID-19 compared to placebo.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, 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."
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.
Read also: AstraZeneca Covid-19 vaccine shows 74 percent efficacy in US trial
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