Pfizer submits new drug application to FDA for its COVID-19 treatment Paxlovid
Pfizer announced this morning it submitted a new drug application to formally ask the U.S. Food and Drug Administration for full approval of its COVID-19 treatment Paxlovid for patients who are at high risk for progression to severe illness from the virus.
The submission seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated individuals.
Paxlovid is currently authorized for emergency use for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients, 12 years and older, with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
The submission provides the longer-term follow-up data necessary for acceptance and potential approval.