Pfizer Seeks Full FDA Approval for COVID-19 Treatment PAXLOVID

Pfizer Inc. announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its COVID-19 treatment, PAXLOVID, for individuals at high risk of progressing to severe illness. The drug is currently available under an Emergency Use Authorization (EUA) for similar indications.

The application seeks to broaden the use of PAXLOVID beyond its current emergency authorization, which allows for treatment in both vaccinated and unvaccinated individuals with COVID-19 who are at high risk for severe disease. Pfizer stated that 50-60% of the U.S. population has at least one risk factor for severe COVID-19, such as age, obesity, diabetes, or chronic kidney disease.

According to the company, final results from the EPIC-HR study demonstrated an 86% reduction in the relative risk of hospitalization or death compared to placebo. No deaths were observed in the PAXLOVID group through 24 weeks, versus 15 deaths in the placebo group. Pfizer Chairman and CEO Albert Bourla expressed anticipation for working with the FDA toward full regulatory approval.