AstraZeneca submits EUA request for COVID-19 prophylaxis
AstraZeneca this week submitted an emergency use authorization request to the FDA for AZD7442, a long-acting monoclonal antibody cocktail to be used for pre-exposure prophylaxis for symptomatic COVID-19 in adults.
The submission was based partly on data that were presented during IDWeek.
“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 and development at AstraZeneca, said in a press release. “With this first global regulatory filing, we are one step closer to providing an additional option to help protect against COVID-19 alongside vaccines.”
AstraZeneca said the EUA request includes safety and efficacy data from the PROVENT and STORM CHASER trials.
The PROVENT trial investigated the efficacy and safety of AZD7442 among more than 5,000 unvaccinated adults aged 18 years or older without prior SARS-CoV-2 infection who could benefit from immunoprophylaxis with antibodies because of an increased risk for severe illness or exposure.
The phase 3 trial demonstrated that AZD7442 reduced the risk for developing symptomatic COVID-19 by 77% (CI 95%, 46%-90%) compared with placebo, and was well-tolerated.
The phase 3 STORM CHASER trial assessed the safety and efficacy of AZD7442 for the prevention of symptomatic COVID-19 among more than 1,100 unvaccinated adults aged 18 years or older who were exposed to SARS-CoV-2 within the past 8 days.
Overall, the study demonstrated that AZD7442 reduced the risk for developing symptomatic COVID-19 by 33% (95% CI, -26% to 65%) compared with placebo. The result was not statistically significant and the trial did not meet its primary endpoint.
According to AstraZeneca, AZD7442 would be the first long-acting antibody to receive an EUA for COVID-19 prevention.
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