AstraZeneca Seeks EUA for Prevention of COVID-19

AstraZeneca has submitted a request to the FDA for an emergency use authorization (EUA) for AZD7442, its long-acting antibody (LAAB) combination, for the prevention of symptomatic COVID-19.

If granted, AZD7442 would be the first LAAB to receive an EUA for COVID-19 prevention. It is the first LAAB with phase 3 data demonstrating a statistically significant reduction in the risk of developing symptomatic COVID-19 compared with placebo.

AstraZeneca presented positive data from a phase 3 study of its monoclonal antibody treatment for COVID-19 at the 10th Annual IDWeek Virtual Conference, September 29 to October 3.

That data showed that AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% compared with placebo, AstraZeneca said when originally announcing the results in August. The trial population included people with co-morbidities and who may be in need of additional protection from SARS-CoV-2 infection. Greater than 75% of participants presented with co-morbidities associated with an increased risk of severe disease or a reduced immune response to vaccination.

Related: AstraZeneca Presents Positive Results for COVID-19 Monoclonal Antibody, RSV Treatments

Mene Pangalos, Ph.D.

“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, BioPharmaceuticals R&D, AstraZeneca, said in a statement.

AZD7442 is a combination of two LAABs — tixagevimab (AZD8895) and cilgavimab (AZD1061) — derived from B-cells donated by convalescent patients after SARS-CoV-2 virus. Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein.

AstraZeneca is also studying AZD7442 in a phase 3 trial to treat mild-to-moderate COVID-19 infection.