Pfizer asks for formal U.S. approval of oral COVID treatment Paxlovid
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[July 01, 2022]
(Reuters) -Pfizer Inc said on
Thursday it is seeking full U.S. approval for its oral COVID-19
antiviral treatment Paxlovid, which is currently available under an
emergency use authorization (EUA).
Pfizer said it submitted a New Drug Application for Paxlovid to the Food
and Drug Administration for the treatment of COVID-19 in vaccinated and
unvaccinated people at high risk of progression to severe illness.
That is basically consistent with the drug's current EUA, which Pfizer
said covers 50% to 60% of the U.S. population, citing estimates from the
U.S. Centers for Disease Control and Prevention.
A full approval could mean the company would have the option to sell
Paxlovid on the open market like other drugs, depending on whether or
not the U.S. government decides to stop buying the drug and providing it
for free nationwide.
Also, "the company might have more control over educating the public
with commercials, or however they want, to boost uptake," said Karen
Andersen, healthcare strategist at Morningstar.
The two-drug treatment taken for five days beginning shortly after onset
of COVID symptoms reduced the risk of hospitalization or death by 88% in
non-hospitalized, high-risk adult patients in Pfizer's clinical trial,
which did not included vaccinated people.
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Pfizer's coronavirus disease (COVID-19) pill Paxlovid is packaged in
Ascoli, Italy, in this undated image obtained by Reuters on November
16, 2021. Pfizer/Handout via REUTERS
Data from a study in Israel earlier
this month showed Paxlovid reduced COVID-19 hospitalization and
death rates in vaccinated and unvaccinated patients 65 years and
older, but was not found to prevent severe illness among younger
adults.
More than 1.6 million courses of Paxlovid have been administered in
the United States, according to data from the Department of Health
and Human Services.
(Reporting by Michael Erman and Manas MishraEditing by Bill Berkrot
and Mark Potter)
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