FDA Revises Paxlovid, Lagevrio EUAs Removing Positive COVID-19 Test Requirement

The Food and Drug Administration (FDA) has updated the Emergency Use Authorizations (EUAs) for Paxlovid^™ (nirmatrelvir tablets; ritonavir tablets) and Lagevrio^™ (molnupiravir) removing the requirement for positive SARS-CoV-2 test results prior to prescribing.

The update was made to cover instances where a health care provider might deem it appropriate to prescribe oral antiviral treatment to an individual with a recent known exposure who develops signs and symptoms consistent with COVID-19 and is at high risk for progression, but tests negative for the virus. Though no longer a requirement, the FDA continues to recommend direct SARS-CoV-2 testing to help diagnose COVID-19.

Paxlovid is authorized for the treatment of mild to moderate COVID-19 in patients 12 years of age and older weighing at least 40kg, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Lagevrio is authorized for the treatment of mild to moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom other COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.

Reference

COVID-19 EUA testing requirement change. News release. US Food and Drug Administration. Accessed February 1, 2023. https://www.fda.gov/media/155050/download.