‘A major step forward’: FDA issues EUA for Pfizer’s COVID-19 antiviral pill
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The FDA on Wednesday issued an emergency use authorization for Pfizer’s Paxlovid, making it the first available oral antiviral treatment for COVID-19.
The EUA is for people aged 12 years or older who test positive for SARS-CoV-2 infection and are at high risk for severe disease.
Paxlovid is available by prescription only and should be taken as soon as possible after a patient is diagnosed with COVID-19, and within 5 days of symptom onset, the FDA said.
Pfizer previously reported that the antiviral reduced COVID-19-related hospitalizations and deaths by almost 90% in a phase 2/3 study of nonhospitalized adults at high-risk for severe infection, according to a final analysis of the data.
The study demonstrated a reduction in the risk for COVID-19-related hospitalization and death of 89% among patients who received the antiviral within 3 days of experiencing symptoms and 88% among participants who received it within 5 days, Pfizer said.
“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, MD, who heads the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”
The FDA noted that Paxlovid is not authorized for pre- or post-exposure prevention of COVID-19 or for people who require hospitalization because of severe or critical COVID-19, nor is it a substitute for vaccination.
It consists of the protease inhibitor nirmatrelvir and a low dose of ritonavir, which helps slow down the metabolism of nirmatrelvir “to help it remain in the body for a longer period at higher concentrations,” the FDA said. It is administered in three tablets — two of nirmatrelvir, and one of ritonavir — that are taken together orally twice daily for 5 days, for a total of 30 pills. It is not authorized to be taken for more than 5 consecutive days.
Pfizer announced previously that it would allow generic drug makers to manufacture the antiviral for low- and middle-income countries under an agreement with the Medicines Patent Pool.
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FDA. Coronavirus (COVID-19) Update: FDA authorizes first oral antiviral for treatment of COVID-19. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19. Accessed Dec. 22, 2021.
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