AstraZeneca has submitted a request to the U.S. Food and Drug Administration (FDA) for an emergency use authorization (EUA) for AZD7442, its long-acting antibody combination for protection against symptomatic COVID-19.
If granted, AZD7442 would be the first long-acting antibody to receive an EUA for COVID-19 prevention, the company said.
AstraZeneca said Phase III data demonstrated a statistically significant reduction in the risk of developing symptomatic COVID-19 compared to placebo.
In August 2021, AstraZeneca announced high-level results from the PROVENT pre-exposure prophylaxis trial which showed AZD7442 reduced the risk of developing symptomatic COVID-19 by 77%, compared to placebo. Importantly, 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 in PROVENT presented with comorbidities associated with an increased risk of severe disease or a reduced immune response to vaccination. The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis. AZD7442 was well-tolerated.
Preliminary ‘in vitro’ findings demonstrate that AZD7442 demonstrates broad anti-COVID activity and neutralizes recent emergent SARS-CoV-2 viral variants, including the Delta and Mu variants.
AZD7442 is being studied in a comprehensive clinical trial program for both prevention and treatment of COVID-19 in over 9,000 participants.
