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Pfizer asks for formal U.S. approval of oral COVID treatment Paxlovid

Stock Markets Jun 30, 2022 01:41PM ET
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© Reuters. FILE PHOTO: 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

(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 (NYSE:PFE) 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.

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.

Pfizer asks for formal U.S. approval of oral COVID treatment Paxlovid
 

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Comments (3)
Me comment
Me comment Jun 30, 2022 2:48PM ET
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All Paxlovid does it cut symptoms until you stop taking it then the symptoms come back worse than originally.
Brad Albright
Brad Albright Jun 30, 2022 1:44PM ET
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But does it work on horse worms?
Harsha Rao
Harsha Rao Jun 30, 2022 6:53AM ET
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$PFE your covid money milking days are over. Go and find the next tragedy to make money out of misery.
 
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