Positive data in hand, AstraZeneca will seek approval for COVID prevention drug

AstraZeneca's combo antibody therapy reduced the risk of people developing COVID-19 symptoms by 77% in a late-stage trial and the drugmaker plans to ask the U.S. FDA for Emergency Use Authorization.

Positive high-level results from the PROVENT phase 3 pre-exposure prophylaxis trial showed AstraZeneca's AZD7442 achieved a statistically significant reduction in the incidence of symptomatic COVID-19. AZD7442 — a combination of two long-acting antibodies derived from B-cells donated by convalescent patients — is the first antibody combination modified to potentially provide long-lasting protection that has demonstrated prevention of COVID-19 in a clinical trial.

The trial of 5,197 participants with no history of COVID exposure showed a 77-percent reduced risk of developing symptomatic disease, with no severe cases recorded, More than 75% of participants had co-morbidities, which include conditions that have been reported to cause a reduced immune response to vaccination. 

The therapy trial results were taken three months after the antibodies were injected — AstraZeneca is hoping to tout the shot as a year-long shield. AstraZeneca is in the process of preparing regulatory submission of the data to health authorities for potential emergency use authorization or conditional approval.

The U.S. government has funded the development of AZD7442 and has agreements to receive 700,000 doses. 

Read the press release