FDA approves Pfizer COVID-19 treatment

Dec. 23, 2021

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Pfizer’s antiviral treatment, PAXLOVID, for mild to moderate COVID-19 in patients at increased risk of hospitalization or death.

 PAXLOVID (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) was authorized for treatment in adults and pediatric patients (12 years of age and older weighing at least 88 pounds) with positive results from direct SARS-CoV-2 testing.

PAXLOVID is available by prescription only and should be initiated within five days of symptom onset, the FDA said.

The “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, MD, 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 consists of nirmatrelvir, which inhibits a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations. PAXLOVID is administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally twice daily for five days, for a total of 30 tablets.

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