This week, AstraZeneca submitted a request to the FDA for an emergency use authorization for their long-acting antibody cocktail for prophylaxis of COVID-19.
AstraZeneca has submitted an emergency use authorization (EUA) request to the US Food and Drug Administration for AZD7442, a combination of 2 long-acting antibodies (LAAB) for pre-exposure prophylaxis of symptomatic COVID-19 in adults.
“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,” said Mene Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca, in the 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.”
The EUA request filing includes safety and efficacy data from the PROVENT and STORM CHASTER trials, according to the company’s press release.
The PROVENT pre-exposure prophylaxis trial included more than 5000 unvaccinated adults aged ≥18 years without prior SARS-CoV-2 infection who could benefit from immunoprophylaxis with antibodies because of an increased risk for severe illness or exposure. Participants were randomized in a 2:1 ratio to receive a single intramuscular dose of either 300mg of AZD7442 or placebo.
The results showed that AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% (95% CI, 46%-90%) compared with placebo, and was well-tolerated, the company stated in an August 2021 press release.
The phase 3 STORM CHASER trial assessed the safety and efficacy of AZD7442 for the prevention of symptomatic COVID-19 among over 1100 unvaccinated adults aged ≥18 years who were exposed to SARS-CoV-2 within the last 8 days.
Overall, results showed AZD7442 reduced the risk for developing symptomatic COVID-19 by 33% (95% CI, -26%-65%) compared with placebo, which was not statistically significant, noted AstraZeneca in a June 2021 statement.
In addition, the company reports that preliminary in vitro studies with AZD7442 demonstrate broad anti-COVID activity, importantly neutralizing recent emergent SARS-CoV-2 viral variants of concern, including the Delta and Mu variants.
AZD7442 would be the first LAAB to receive an EUA for COVID-19 prevention if the request is granted, according to AstraZeneca.