AstraZeneca seeks U.S. authorisation of drug to prevent COVID-19
Send a link to a friend
[October 05, 2021]
By Ludwig Burger and Sachin Ravikumar
(Reuters) -AstraZeneca has requested
emergency use authorisation 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%.
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.
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.
![](http://archives.lincolndailynews.com/2016/Aug/26/images/ads/current/ldn_sda_062409.png)
A U.S. authorisation 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.
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.
[to top of second column]
|
![](../images/100521PIX/news_I15.jpg)
The logo for AstraZeneca is seen outside its North America
headquarters in Wilmington, Delaware, U.S., March 22, 2021.
REUTERS/Rachel Wisniewski
![](../images/ads/current/centraldirect_lda_SPONSOR_2021.png)
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 immunised have
received shots from the Pfizer-BioNTech alliance, Moderna or Johnson
& Johnson.
Astra said in July it expected to seek U.S. approval for the vaccine
in the second half of this year.
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)
[© 2021 Thomson Reuters. All rights
reserved.] Copyright 2021 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
Thompson Reuters is solely responsible for this content.
![](http://archives.lincolndailynews.com/2021/Oct/05/images/ads/current/fcs_funeral_lda082613.png) |