|
 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.
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.
[to top of second column] |
 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 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)
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