FDA panel OKs Paxlovid as COVID-19 treatment

An FDA advisory panel backed the use of Pfizer’s nirmatrelvir/ritonavir antiviral (Paxlovid) as a treatment for adults with COVID-19 who are at high risk for severe illness. The endorsement is expected to allow the drug, which is available under an EUA, to receive full FDA approval.

Pharmacists are able to order and prescribe the oral antiviral, under certain conditions, for eligible patients who have COVID-19.

The advisory panel voted 16–1 after FDA issued a new evaluation indicating that the drug reduced hospitalization and death among both unvaccinated and vaccinated people with COVID-19. Using data on COVID-10 rates in January 2023, agency researchers estimated the drug could “lead to 1,500 lives saved and 13,000 hospitalizations averted each week in the United States.”

FDA’s evaluation did find evidence of rebound among patients receiving the treatment. However, the data also indicated that some patients who did not receive the antiviral also experienced rebound. FDA said there was no noticeable difference in rebound rates between the two groups, and that rebound had no effect on the risk of developing severe illness.