AstraZeneca PLC (LSE:AZN) has requested authorisation in the US for emergency use of its new antibody combination against COVID-19 to protect people with a poor immune response to vaccines.
The drug company said its Emergency Use Authorisation (EUA) filing to the US Food and Drug Administration (FDA) included data announced in August from its PROVENT phase III trial, which showed a 77% reduction in risk of developing symptomatic COVID-19 with AZD7442, its long-acting antibody combination (LAAB).
The drug is the first LAAB with phase III data demonstrating “a statistically significant reduction in the risk of developing symptomatic COVID-19” compared to placebo, AstraZeneca said.
If granted, AZD7442 would be the first LAAB combination to receive an EUA for COVID-19 prevention.
Mene Pangalos, executive vice president of BioPharmaceuticals R&D at AstraZeneca, said: “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.”
AstraZeneca said it is holding discussions regarding supply agreements for AZD7442 with the US and other governments.