Paxlovid EUA revised, emergency use still authorized in pediatric patients

Paxlovid EUA revised, emergency use still authorized in pediatric patients | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.

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.

Reference:

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