The Food and Drug Administration granted full approval for Pfizer’s Covid antiviral pill Paxlovid for high-risk adults, nearly a year and a half after the drug received an emergency use authorization, as hospitalization and death rates continue to decline.
The FDA granted full approval for Pfizer's oral Covid antiviral pill Paxlovid.
The FDA announced its approval of the oral pill in a statement Thursday, giving doctors more flexibility to prescribe the pill for adults with mild to moderate Covid-19 who are at high risk of developing severe Covid, being hospitalized by the virus or dying.
The approval comes as demand for Paxlovid, which was granted an emergency approval in December 2021, declines as hospitalization and death rates drop in the U.S. and as the World Health Organization ended its global health emergency status for Covid after more than three years.
Paxlovid sales in the first three months of 2023 bounced back to surpass analysts’ expectations, with $4.1 billion in sales.
The FDA last July allowed pharmacists to prescribe Paxlovid to eligible patients 12 years and older at high risk of developing more severe Covid.
In a statement, Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, said the full approval demonstrates Paxlovid “remains an important treatment option for people at high risk for progression to severe Covid-19.”
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