AstraZeneca files for FDA green light of COVID-preventing antibody

Mene Pangalos
AstraZeneca Executive Vice President Mene Pangalos (AstraZeneca)

AstraZeneca has taken another step toward bringing its COVID-19 antibody cocktail to market, filing for emergency use authorization of the long-acting candidate in coronavirus prophylaxis in the U.S. 

Last month, AstraZeneca delivered evidence that the candidate prevents COVID-19 in people who are unlikely to respond well to vaccines, bouncing back from an earlier failure to report a 77% reduction in the risk of symptomatic coronavirus infection. With all three cases of severe COVID-19 happening in the placebo cohort, AstraZeneca emerged from the study with evidence that it can protect some of the most vulnerable people from the coronavirus.

“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,” Mene Pangalos, executive vice president for biopharmaceuticals R&D at AstraZeneca, said in a statement. 

AstraZeneca included data from the successful COVID-19 prevention clinical trial and an earlier study that tested the antibody combination in people recently exposed to the coronavirus. The earlier trial missed its primary endpoint, but the later success of the prevention study validated AstraZeneca’s focus on a subgroup analysis of people who were PCR-negative at baseline. In the preplanned subgroup, AstraZeneca reported a relative risk reduction of 73%.

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The available data point to the ability of AZD7442 to prevent COVID-19. If regulators agree the benefits outweigh the risks, AstraZeneca will then face the challenge of making the commercial case for the use of its product. 

AstraZeneca is currently in talks with governments in the U.S. and other countries about AZD7442 supply deals. At a recent press conference to discuss AZD7442, Hugh Montgomery, professor of intensive care medicine at University College London, set out the value he sees in societies deploying the product. 

“The subjects themselves basically got an intramuscular shot of the dual monoclonal and walked out the door, which again, as a practicing clinician, especially when health services are stressed, is a really, really big advantage over having to admit people for intravenous infusions, for instance. So this is going to be a sort of point and shoot weapon as it were, for tackling COVID,” Montgomery said.