(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 for 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.
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.
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