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AstraZeneca seeks U.S. emergency approval for COVID-19 prevention drug

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AstraZeneca has requested emergency use authorization from U.S. regulators for its new treatment to prevent COVID-19 for people who respond poorly to vaccines because of a weakened immune system.

In a statement on Tuesday, the Anglo-Swedish drugmaker said it included data in its filing with the Food and Drug Administration from a late-stage trial that showed the drug reduced the risk of people developing any COVID-19 symptoms by 77 per cent.

The antibody therapy called AZD7442 could protect people who do not have a strong enough immune response to COVID-19 vaccines or to supplement a vaccination course for those, such as military personnel, who need to booster their protection further, AstraZeneca has said.

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While vaccines rely on an intact immune system to develop 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.

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A U.S. authorization for AZD7442 – based on two antibodies discovered by Vanderbilt University Medical Center in the United States – could be a major win for AstraZeneca, whose widely used COVID-19 vaccine has yet to be approved by U.S. authorities.

Talks regarding supply agreements for AZD7442 are ongoing with the United States and other governments, AstraZeneca said.

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COVID-19 therapies based on the same class of monoclonal antibodies are being developed by rivals Regeneron, Eli Lilly and GlaxoSmithKline with partner Vir, competing for a role in COVID-19 treatment and prevention. But Astra’s filing has cemented its lead in prevention.

That contrasts with delays in Astra’s quest for approval for its COVID-19 vaccine Vaxzevria in the United States, where the vast majority of those willing to get immunized have received shots from the Pfizer-BioNTech alliance, Moderna or Johnson & Johnson.

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Astra said in July it expected to seek U.S. approval for the vaccine in the second half of this year.

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Trial results on the AZD7442 therapy, first published in August, were taken three months after injection but the company hopes it can tout the shot as a year-long shield as trial investigators will follow up with participants as far out as 15 months.

(Reporting by Sachin Ravikumar in Bengaluru and Ludwig Burger in Frankfurt; Editing by Sriraj Kalluvila and Barbara Lewis)

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