The U.S. Food and Drug Administration approved Pfizer Inc's COVID-19 oral antiviral pill Paxlovid for the treatment of mild-to-moderate COVID-19 in adults. Paxlovid is the first oral treatment, and the fourth drug, approved by the agency to treat COVID-19 in adults.
Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) has been approved to treat adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
Under the FDA emergency use authorization or EUA, Paxlovid is currently distributed by the U.S. Department of Health and Human Services. It will continue to be available to ensure continued access for adults, as well as treatment of eligible children ages 12-18 who are not covered by latest approval.
Meanwhile, Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of COVID-19, the FDA noted.
According to the agency, the efficacy of Paxlovid was primarily supported by the final results of the EPIC-HR clinical trial. The randomized, double-blind, placebo-controlled clinical trial studied Paxlovid for the treatment of non-hospitalized symptomatic adults with a laboratory confirmed diagnosis of SARS-CoV-2 infection.
Benefit of Paxlovid was observed in patients with prior immunity to the virus that causes COVID-19.
Patrizia Cavazzoni, director for the FDA's Center for Drug Evaluation and Research, said, "Today's approval demonstrates that Paxlovid has met the agency's rigorous standards for safety and effectiveness, and that it remains an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity."
The FDA's Antimicrobial Drugs Advisory Committee in March had voted in favor of recommending a full approval for Paxlovid in adults at high risk of progression to severe disease.
In February 2023, the European Commission granted standard Marketing Authorization of Paxlovid for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe.
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