The Food and Drug Administration (FDA) on Thursday granted full approval to Pfizer’s COVID-19 oral antiviral pill Paxlovid for use in adults who are at high risk for progression to severe disease.
The agency’s approval comes nearly a year and a half after the drug received an emergency use authorization and as hospitalization and deaths from the virus continue to decline.
Paxlovid is given as a five-day treatment course, and the FDA said it should be initiated as soon as possible after a diagnosis of COVID-19 has been made, but no more than five days after symptom onset.
The drug is specifically advised for use in people aged 50 and older as well as those who suffer from certain medical conditions that put them at high risk of developing complications, including hospitalization and severe disease from COVID-19.
In March, an FDA independent advisory committee recommended the agency fully approved Paxlovid, finding the medicine was safe and effective for treating COVID-19 in high-risk adults based on three of Pfizer’s clinical trials.
The agency further said Paxlovid does not cause “rebound” COVID-19 infection.
Paxlovid has been shown to be most effective among patients who have not received a COVID-19 vaccine and those who have not been previously infected.
One of Pfizer’s clinical trials showed Paxlovid significantly reduced the proportion of people with COVID-19 related hospitalization or death by 86 percent compared to placebo among patients treated within five days of symptom onset — and by 89 percent in those treated within three days.
“Today’s approval demonstrates that Paxlovid has met the agency’s rigorous standards for safety and effectiveness, and that it remains an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity,” said Patrizia Cavazzoni, director for the FDA’s Center for Drug Evaluation and Research.
“The FDA remains committed to working with sponsors to facilitate the development of new prevention and treatment options for COVID-19,” she said.
The federal government owns 1.1 million doses of Paxlovid that it already purchased and are available at pharmacies nationwide.
Once that stockpile is used up, distribution will shift to the private sector, and Pfizer will sell directly to health providers. The company sells to the government for about $530 for a five-day course of treatment, but it has not said what it will charge commercially.