FDA revises EUA for COVID-19 treatment Paxlovid

Having first authorized US pharma giant Pfizer’s (NYSE: PFE) Paxlovid (nirmatrelvir and ritonavir) for emergency use in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death in December 2021, and amended this in May 2023, the US Food and Drug Administration (FDA) is now making another amendment.

Yesterday, the FDA announced a revision to the Paxlovid emergency use authorization (EUA), stating that Paxlovid manufactured and labeled in accordance with the EUA (EUA-labeled Paxlovid) currently in U.S. distribution will remain authorized for use through the labeled or extended expiration date, as applicable, or through March 8, 2024, whichever is earlier.

EUA-labeled Paxlovid will no longer be authorized for emergency use after March 8, 2024, regardless of the labeled or extended expiration date. However, the Paxlovid EUA will continue to authorize emergency use of Paxlovid manufactured and labeled in accordance with the new drug application (NDA-labeled Paxlovid) for the treatment of mild-to-moderate COVID-19 in pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death.