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 The antibody cocktail, Evusheld, is only authorized for adults and
adolescents who are not currently infected with the novel
coronavirus and have not recently been exposed to an infected
individual, the regulator said.
The authorization for the therapy, made up of two monoclonal
antibodies tixagevimab and cilgavimab, marks a significant step for
AstraZeneca, whose widely used COVID-19 vaccine is yet to be
approved by U.S. authorities.
AstraZeneca last month had agreed to supply the U.S. government with
700,000 doses of Evusheld, which had earlier shown to cut the risk
of people developing any COVID-19 symptoms by 77% in a late-stage
trial.
While vaccines rely on an intact immune system to develop targeted
antibodies and infection-fighting cells, Evusheld contains lab-made
antibodies designed to linger in the body for months to contain the
virus in case of an infection.
AstraZeneca's therapy, given in two sequential injections, is
designed to last several months to a year.
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 Although vaccines currently
provide the best defense against COVID-19,
certain immune compromised individuals or those
who have a history of severe adverse reactions
to a vaccine need an alternative prevention
option, said Patrizia Cavazzoni, director of the
FDA's Center for Drug Evaluation and Research.
However, the FDA added that pre-exposure prevention
with Evusheld is not a substitute for vaccination in individuals for
whom COVID-19 vaccination is recommended.
Monoclonal antibodies aim to stop COVID-19 from worsening during
early, milder stages. Drugmakers such as Eli Lilly, Regeneron, and
GlaxoSmithKline with partner Vir make similar therapies.
(Reporting by Manas Mishra and Bhanvi Satija in Bengaluru; Editing
by Shounak Dasgupta)
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