AstraZeneca Seeks Emergency Nod In US For AZD7442 To Prevent Symptomatic COVID-19

AstraZeneca Plc. (AZN) said Tuesday that it has submitted a request to the US Food and Drug Administration for an Emergency Use Authorization for its long-acting antibody combination, AZD7442, for prevention of symptomatic COVID-19.

The EUA request filing includes data from PROVENT Phase III trial showing 77% reduction in risk of developing symptomatic COVID-19 with long-acting antibody combination, the company said in a statement.

Preliminary 'in vitro' findings showed that AZD7442 demonstrates broad anti-COVID activity, and in particular neutralises recent emergent SARS-CoV-2 viral variants, including the Delta and Mu variants.

The company said it is discussing with the US Government as well as other governments around the world regarding supply agreements for AZD7442.

AZD7442 is a combination of two long-acting antibodies - tixagevimab (AZD8895) and cilgavimab (AZD1061) - derived from B-cells donated by convalescent patients after SARS-CoV-2 virus.

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