AstraZeneca (LON:AZN) has filed paperwork with the FDA for an emergency use authorization (EUA) for AZD7442, a long-acting antibody (LAAB) cocktail, as a COVID-19 prophylaxis.
The paperwork filed for the EUA request includes data from the PROVENT and STORM CHASER Phase 3 trials.
A Phase 3 trial of AZD7442 showed statistically significant protection against COVID-19 infection. Compared to the placebo, the investigational drug offered 77% protection in the PROVENT trial against symptomatic disease compared to placebo.
The PROVENT study included 5,197 participants, with two-thirds receiving AZD7442 and the remainder getting placebo.
A single injection of AZD7442 could offer up to 12 months of protection from symptomatic SARS-CoV-2 infection.
The study also found that the drug was well-tolerated.
AstraZeneca foresees that the drug would be used alongside vaccines to protect vulnerable populations.
AZD7442 comprises two agents, tixagevimab (AZD8895) and cilgavimab (AZD1061), which were developed based on B-cells from COVID-19 patients.
There are currently no LAAB drugs that are authorized to prevent COVID-19 in the U.S.
Last year, AstraZeneca won $486 million in funding from the U.S. government to pursue the development of AZD7442.
Filed Under: Infectious Disease