Pfizer Inc said Thursday that it has applied for US approval for widespread use of its oral antiviral treatment. Paxlovid against Covid-19, which is currently available under an emergency use authorization.
The company stated that it filed a new drug application for Paxlovid with the Food and Drug Administration (FDA) for the treatment of COVID-19 in vaccinated and unvaccinated persons at high risk of progression to severe disease.
The request is substantially consistent with the drug’s current emergency authorization, which according to Pfizer it covers between 50% and 60% of the US population, citing estimates from the Centers for Disease Control and Prevention (CDC).
The two-drug treatment given for five days 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 include vaccinated people.
Data from a study in Israel earlier this month showed that Paxlovid reduced rates of hospitalization and death from Covid-19 by vaccinated patients and unvaccinated 65 years and older, but it was not found to prevent severe disease among younger adults.
More than 1.6 million Paxlovid therapies have been administered in the United States, according to data from the Department of Health and Human Services.
