The Food and Drug Administration authorized the first oral antiviral treatment for COVID-19, Pfizer's Paxlovid drug.
Emergency use authorization was granted Wednesday for Pfizer's Paxlovid – nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use – for the treatment of mild-to-moderate coronavirus disease in adults and children 12 years of age or older weighing at least 40 kilograms or about 88 pounds.
It applies only to those who meet those qualifications, have tested positive for SARS-CoV-2 testing and "who are at high risk for progression to severe COVID-19, including hospitalization or death," the FDA 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.
"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 in a statement. "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. Paxlovid is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended, the FDA said.
The FDA still "urges the public to get vaccinated and receive a booster if eligible."
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, the FDA said.
Treatment involves taking three tablets -- two tablets of nirmatrelvir and one tablet of ritonavir -- together orally twice daily for five days, for a total of 30 tablets. Paxlovid is not authorized for use for longer than five consecutive days.
Emergency authorization is different than FDA approval. At this stage, the agency has determined that the known and potential benefits of Paxlovid, when used consistent with the terms and conditions of the authorization, outweigh the known and potential risks. The FDA also said that at this time there are no adequate, approved and available alternatives to Paxlovid for the treatment of COVID-19.
In a randomized, double-blind, placebo-controlled clinical trial, Paxlovid significantly reduced the proportion of people with COVID-19 related hospitalization or death from any cause by 88% compared to placebo among patients treated within five days of symptom onset and who did not receive COVID-19 therapeutic monoclonal antibody treatment.
The safety and effectiveness of Paxlovid for the treatment of COVID-19 continue to be evaluated, the FDA said.