Oct 5 (Reuters) – AstraZeneca (AZN.L) has requested the U.S. Food and Drug Administration to grant emergency use authorisation for its new treatment to prevent COVID-19, the British drugmaker said on Tuesday.
The company has included data from a late-stage trial of over 5,000 participants that showed the drug reduced the risk of people developing any COVID-19 symptoms by 77%.
The treatment, an antibody therapy called AZD7442, could help protect people who may not have a strong enough immune response to COVID-19 vaccines, AstraZeneca said.
While vaccines rely on an active immune system to develop an arsenal of targeted antibodies and infection-fighting cells, AZD7442 contains lab-made antibodies designed to linger in the body for months to contain the virus in case of an infection.
A U.S. authorisation for AZD7442 could be a major win for AstraZeneca, whose widely used COVID-19 vaccine is yet to be approved in the United States.
Talks regarding supply agreements for AZD7442 are ongoing with the United States and other governments, AstraZeneca said.
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