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AstraZeneca requests Emergency Use Authorization from FDA for COVID-19 antibody

Phase 3 data shows the long-acting antibody combination produces a 77% reduction in the risk of developing symptomatic COVID-19


AstraZeneca has submitted a request to the US Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for AZD7442, its long-acting antibody (LAAB) combination, to be used to reduce the risk of developing 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 3 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,” he added.

The filing is based on data from the PROVENT and STORM CHASER phase 3 trials demonstrating the safety and efficacy of AZD7442, which were announced earlier this year.

Importantly, the trial population included people with co-morbidities who may be in need of additional protection from SARS-CoV-2 infection.

More than 75% of the participants in the PROVENT phase 3 trial had co-morbidities associated with an increased risk of severe disease or a reduced immune response to vaccination.

People who are immunocompromised (or have weakened immune systems due to cancer, chronic kidney, or other conditions) have an especially high risk for developing severe COVID-19 symptoms, as their bodies may not be able to mount a proper response to vaccines. An EUA for AZD7442 could provide a new essential layer of protection.

Clinical studies have also observed preliminary ‘in vitro’ findings that demonstrate AZD7442 neutralises recent emergent SARS-CoV-2 viral variants, including the Delta and Mu variants.

Article by
Iona Everson

6th October 2021

From: Research, Regulatory



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