Paxlovid EUA Revision Narrows Emergency Use to Pediatric Patients

Emergency use authorization-labeled (EUA) nirmatrelvir and ritonavir (Paxlovid; Pfizer) will no longer be authorized for emergency use in adults after March 8, 2024, though the emergency use will continue in pediatric patients.

A revision in the EUA for nirmatrelvir and ritonavir in adults who are at high risk for progression to severe COVID-19 means nirmatrelvir and ritonavir currently in United States distribution will remain authorized for use through the labeled or extended expiration date, or March 8, 2024, whichever is earlier.

“However, the [nirmatrelvir and ritonavir] EUA will continue to authorize emergency use of [nirmatrelvir and ritonavir] manufactured and labeled in accordance with the NDA (NDA-labeled [nirmatrelvir and ritonavir]) for the treatment of mild-to-moderate COVID-19 in pediatric patients (12 years of age and older weighing at least [88 lbs] 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death,” the FDA stated in a press release.

This revision comes after the FDA approved Pfizer’s New Drug Application (NDA) for nirmatrelvir and ritonavir to treat mild-to-moderate COVID-19 in adults who are at high risk for progressions to severe COVID-19, including hospitalization.

The FDA states the revision to the EUA is the next phase in the transition from the use of EUA-labeled nirmatrelvir and ritonavir to the use of NDA-labeled nirmatrelvir and ritonavir. With the introduction of FDA-approved nirmatrelvir and ritonavir (NDA-labeled), the transition began on November 1, 2023.

Patients who have a prescription continue to receive either EUA-labeled or NDA-labeled nirmatrelvir and ritonavir through March 8, 2024. After, only NDA-labeled nirmatrelvir and ritonavir will be received, the federal agency stated.

Differences in packaging between the 2 labels along with additional answers to frequently asked questions can be found here.

Through March 8, 2024, unexpired EUA-labeled nirmatrelvir and ritonavir can be dispensed to patients when consistent with the terms of the EUA.

This article originally appeared in Contemporary Pediatrics.

Reference

1. FDA revises letter of authorization for the emergency use authorization for Paxlovid. FDA. Press release. January 29, 2024. Accessed January 29, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/fda-revises-letter-authorization-emergency-use-authorization-paxlovid?utm_medium=email&utm_source=govdelivery