AstraZeneca Requests FDA EUA for COVID-19 Antibody Combination

AstraZeneca recently submitted a request to FDA for an emergency use authorization for its long-acting COVID-19 antibody combination, AZD7442.

AstraZeneca optimized AZD7442 using its YTE half-life extension technology, which more than triples the durability of action compared to conventional antibodies. 

If granted, AZD7442 will be the first long-acting antibody combination to receive emergency use authorization for COVID-19 prevention. So far, AZD7442 has shown a significant reduction in the risk of developing symptomatic COVID-19 compared to placebo. 

“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,” Mene Pangalos, executive vice president of biopharmaceuticals research & development at AstraZeneca, said in the recent announcement.

“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,” Pangalos continued. 

The emergency use authorization filing includes safety and efficacy data from the PROVENT and STORM CHASER trials. 

In August 2021, AstraZeneca announced that AZD442 reduced the risk of symptomatic coronavirus by 77 percent compared to placebo in the Phase 3 PROVENT trial.

Researchers conducted the trial in 87 sites in the US, UK, Spain, France, and Belgium. Notably, the trial population included individuals with co-morbidities and those who may need additional protection from the virus. 

In the trial, over 75 percent of participants presented with co-morbidities associated with an increased risk of severe disease or a reduced immune response to vaccination.

Overall, there were no cases of severe COVID-19 or COVID-19-related death in those treated with AZD7442. But there were three cases of severe COVID-19 in the placebo arm and two deaths. 

And in the STORM CHASER trial, AZD7442 reduced the risk of developing symptomatic COVID-19 by 33 percent. Although these results are not statically significant, they suggest that the antibody combination may help prevent symptomatic COVID-19 in individuals not already infected.

But the PROVENT trial gave researchers more clarity on the actual effects of AZD7442. 

Currently, discussions regarding supply agreements for AZD7442 are ongoing with the US and other governments globally.