FDA Updates Letters of Authorization for COVID Drugs Paxlovid and Lagevrio
The FDA has updated its emergency authorizations for Pfizer’s Paxlovid (nirmatrelvir, ritonavir) and Merck’s Lagevrio (molnupiravir) to allow dispensing of the drugs without a positive COVID-19 test.
The agency continues to recommend testing but recognizes that individuals with a recent known exposure may be diagnosed with COVID-19 “even if they have a negative test result,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
The updated authorizations were supported by data from a phase 2/3 clinical trial for Paxlovid and a phase 3 study for Lagevrio.
Paxlovid is authorized for patients who are 12 years and older and who weigh at least 88 pounds with a current diagnosis of mild-to-moderate COVID-19.
Lagevrio is authorized to treat adults with a current diagnosis of mild-to-moderate COVID-19 who are at high risk of progression to severe COVID-19, including hospitalization or death.
February 3, 2023
