Biopharmaceutical company AstraZeneca has officially filed a request to the US Food and Drug Administration (FDA) for emergency use authorisation of AZD7442, a long-acting antibody combination that counters COVID-19.
AZD7442, which is delivered by intramuscular injection, has been studied for both pre-exposure and post-exposure prophylaxis of symptomatic COVID-19. In a Phase III pre-exposure prophylaxis trial, AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% compared to placebo.
Regulatory approval of AZD7442, should it be granted, would be a significant development in the protection of immunocompromised individuals, for whom vaccination against COVID-19 is less effective.
AstraZeneca has not yet submitted AZD7442 for approval by Australia’s medical regulator, the Therapeutic Goods Administration.