Becker's Healthcare May 25, 2023
The FDA granted Pfizer’s popular COVID-19 antiviral treatment, Paxlovid, full approval on May 25.
Paxlovid (nirmatrelvir and ritonavir) was given emergency use authorization in December 2021, and that EUA was tweaked in February 2023 to allow providers to prescribe the drug to patients who do not test positive for COVID-19 but present symptoms.
Other COVID-19 treatments are approved, but Paxlovid is the first approved oral treatment for the coronavirus, according to Pfizer. The jump from emergency use authorization to approval means the FDA reviewed and found positive results from longer data from clinical study participants and the manufacturer’s plants.
The five-day regimen is approved for treating mild to moderate COVID-19 in adults who are at high risk for...