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 progression to more severe outcomes, including hospitalization and death.
On March 16, an FDA advisory committee voted 16-1 that Paxlovid's benefit-risk profile is favorable when used to treat mild to moderate COVID-19 in high-risk adult patients.
"Besides oxygen, Paxlovid has probably been the most — the single most — important treatment tool in this epidemic, and it continues to be," Richard Murphy, MD, one of the committee members and chief of the infectious diseases division at VA White River Junction (Vt.) Medical Center, said during the antimicrobial drugs advisory committee meeting.
The medication's rebound risk — when a person tests negative after taking Paxlovid's five-day regimen before testing positive or experiencing a recurrence of symptoms a few days later — has long been contested. On March 15, the FDA said the risk is not higher than 10 to 16 percent. Read more about rebound risk here and here.