Antibody for Symptomatic COVID-19 Prophylaxis Submitted for Emergency Use Authorization

AstraZeneca is seeking an Emergency Use Authorization (EUA) from the FDA for AZD7442, a long-acting antibody combination (LAAB) for prophylaxis of symptomatic COVID-19, according to a statement from the company.

“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 R&D 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. We look forward to sharing AZD7442 data for the treatment of COVID-19 later this year.”

The EUA request includes safety and efficacy data from the PROVENT trial, which showed that AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% compared to a placebo.

More than 75% of individuals with comorbidities had an increased risk of severe disease or a reduced immune response to vaccination, so they had a greater need for additional protection from COVID-19 infection.

The drug was well-tolerated in the study. Prior results from the PROVENT trial showed AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% (95% CI 46, 90), compared to placebo.

If granted by the FDA, the drug would be the first LAAB to receive an EUA for COVID-19 prevention.

Reference

AZD7442 request for Emergency Use Authorization for COVID-19 prophylaxis filed in US. AstraZeneca. News release. October 5, 2021. Accessed October 5, 2021. https://www.astrazeneca.com/media-centre/press-releases/2021/azd7442-request-for-emergency-use-authorization-for-covid-19-prophylaxis-filed-in-us.html