The FDA on Dec. 22 issued an emergency use authorization for Paxlovid, Pfizer's COVID-19 antiviral pill regimen, making it the first available at-home COVID-19 treatment.
The treatment is intended for COVID-19 patients who are at high-risk of developing severe illness, with the potential to prevent hospitalizations and avert further strain on the healthcare system amid a nationwide surge in cases driven by the highly transmissible omicron variant.
The FDA said Pfizer's prescription pills, which were authorized for use in patients ages 12 and older who weigh at least 88 pounds and are at high risk of progressing to severe illness, should be administered as soon as possible after diagnosis and within five days of developing symptoms. It's administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken twice daily for no more than five consecutive days.
"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, 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."
In a trial involving 2,246 adults, Paxlovid reduced the risk of hospitalization or death by 89 percent in high-risk adults. Pfizer has also said it expects the antiviral to be effective against omicron.
The news comes a day after people familiar with the matter told Bloomberg that the agency was planning to authorize Paxlovid and molnupiravir, a COVID-19 antiviral developed by Merck and Ridgeback Biotherapeutics, though the FDA has only authorized Pfizer's pill so far. On Nov. 30, a panel of FDA advisers narrowly voted to recommend the agency authorize Merck's molnupiravir, with some members citing the drug's efficacy and safety concerns such as pregnancy risks as reasons to vote against recommendation. A final analysis from Merck showed molnupiravir reduced the risk of hospitalization or death by about 30 percent, down from 48 percent in an earlier analysis.
The U.S. has purchased 10 million courses of Pfizer's pill and about 3 million of Merck's antiviral, Bloomberg reports.