This is the first antiviral COVID-19 pill authorised for sick people to take at home before they are sick enough to be hospitalised.
Paxlovid combines a new antiviral drug named nirmatrelvir and an older one called ritonavir and is administered as three pills given twice a day for five days.
In a statement on Wednesday, the FDA said those eligible for the pill include high-risk individuals age 12 and older who weigh at least 88 pounds and have a positive SARS-CoV-2 test are eligible.
It said Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.
Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said the pill is a major step forward in the fight against this global pandemic.
“This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19,“ she said.
The agency, however, warned that “Paxlovid is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in those requiring hospitalization due to severe or critical COVID-19”.
“Paxlovid is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended. The FDA has approved one vaccine and authorized others to prevent COVID-19 and serious clinical outcomes associated with a COVID-19 infection, including hospitalization and death. The FDA urges the public to get vaccinated and receive a booster if eligible,” it said.
It said the side effects of Paxlovid include impaired sense of taste, diarrhea, high blood pressure and muscle aches, adding that using the pill at the same time as certain other drugs may result in potentially significant drug interactions.