The Food and Drug Administration on Wednesday authorized the first Covid-19 antiviral pill in the United States to protect against severe disease, making it the first at-home treatment for the coronavirus.
An at-home treatment for COVID-19 that can prevent serious illness was authorized by the Food and Drug Administration on Wednesday, offering a note of optimism for the future of the pandemic as the world faces the omicron variant.
This is the first antiviral Covid-19 pill authorized for ill people to take at home, before they get sick enough to be hospitalized.High-risk individuals age 12 and older who weigh at least 88 pounds and have a positive SARS-CoV-2 test are eligible for this treatment and will need to have it prescribed by a doctor.
The pill “should be initiated as soon as possible after diagnosis of Covid-19 and within five days of symptom onset,” according to an FDA statement.
“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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.”
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.