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Pfizer seeks formal US approval for oral COVID treatment Paxlovid

Article author:

Reuters

Reuters

Pfizer said Thursday that it is seeking full US approval for Paxlovid, an oral COVID-19 antiviral treatment currently available under an Emergency Use Authorization (EUA).

Pfizer has submitted a new drug application for Paxrovid to the Food and Drug Administration for the treatment of COVID-19 in vaccinated and unvaccinated people at high risk of developing severe illness. Said.

This is basically one with the current EUA of drugs that Pfizer said covers 50% to 60% of the U.S. population, citing estimates from the Centers for Disease Control and Prevention. I am doing it.

Two-drug treatment for 5 days immediately after the onset of COVID symptoms reduced the risk of hospitalization or death in high-risk adult patients without Pfizer hospitalization by 88%. A clinical trial that does not include vaccinated people.

According to data from a study conducted in Israel earlier this month, Paxlovid reduced COVID-19 hospitalization and mortality in vaccinated and non-vaccinated patients aged 65 and over, but younger. It was not possible to prevent serious illness in adults.

According to data from the Department of Health and Human Services, there are over 1.6 million Paxlovid courses in the United States. (Report by Michael Erman, edited by Bill Berkrot)