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(Adds details on treatment, background on vaccine)
By Ludwig Burger and Sachin Ravikumar
Oct 5 (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.
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.
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)
