AstraZeneca Files Request for Emergency Use Authorization for Long-Acting Antibody to Prevent COVID-19

AstraZeneca has submitted a request to the US FDA for an Emergency Use Authorization (EUA) for AZD7442, its long-acting antibody (LAAB) combination, for prophylaxis of symptomatic COVID-19. AZD7442 is a combination cocktail of tixagevimab and cilgavimab, both originating from B-cells donated by patients who recovered from COVID-19. AZD7442 is intended to provide protection for individuals not expected to mount an adequate immune response following vaccination, including the immunocompromised or elderly.

AstraZeneca recently presented data from the phase 3 PROVENT trial and the phase 3 STORM CHASER trial.

The randomized, double-blind, placebo-controlled, multi-center PROVENT trial assessed the safety and efficacy of a single 300mg dose of AZD7442 compared to placebo for the prevention of COVID-19 in 5,197 subjects. AZD7442 reduced the risk of developing symptomatic COVID-19 by 77%, compared to placebo. Over 75% of participants in PROVENT presented with co-morbidities 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. There were no cases of severe COVID-19 ...

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