The U.S. Food and Drug Administration announced in a press release on Wednesday that they have issued an emergency use authorization for Pfizer’s Paxlovid, the first pill for COVID-19 treatment.
Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use), are intended for treatment of mild-to-moderate COVID-19 in high risk adults and pediatric patients that are 12-years-old and older, weighing at least 88 pounds with positive results of direct SARS-CoV-2 testing.
“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,” Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said. “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 available by prescription only and is not authorized for the pre-exposure or post-exposure prevention of COVID-19. Nor is it a substitute for vaccination in people for whom COVID-19 vaccinations and boosters are reccomended.
It 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, and is not authorized for use of more than five days. Nirmatrelvir inhibits a SARS-CoV-2 protein to stop the virus from replicating, while ritonavir slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations.
A clinical trial showed that Paxlovid was highly effective when taken soon after an infection. Pfizer said that it reduced the risk of hospitalization or death by 88 percent when given to a high-risk, unvaccinated person within five days of their initial symptoms.
Supply will be limited at first, but the federal government has ordered enough to cover 10 million people, at the cost of about $530 per patient. Pfizer is expected to deliver to the U.S. enough pills to cover 65,000 Americans within a week of the authorization. The company is expected to deliver another 200,000 treatments in January and another 150,000 in February, and then the pace of deliveries will increase, according to The New York Times.
Patients with severe kidney or severe liver impairment are not recommended to take Paxlovid.
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