Topline
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.
Key Facts
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.
The FDA last July allowed pharmacists to prescribe Paxlovid to eligible patients 12 years and older at high risk of developing more severe Covid.
Contra
Paxlovid sales in the first three months of 2023 bounced back to surpass analysts’ expectations, with $4.1 billion in sales. Pfizer had previously estimated sales of Paxlovid on the year to only reach $8 billion, as demand for Covid vaccines and treatment wanes and the World Health Organization said the pandemic is nearing a “transition” point.
Crucial Quote
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.”
Big Number
9,186. That’s how many people in the U.S. were hospitalized for Covid in the week ending May 11, according to the Centers for Disease Control and Prevention’s final batch of weekly Covid-19 data, marking a 4.9% drop from the previous week.
Key Background
Paxlovid, one of the only available Covid-19 oral antiviral pills in the U.S., had been lauded as a potential game-changer to combat surging coronavirus cases and the rise of the more virulent omicron variant when it given its emergency use authorization in December 2021. It also received praise from the Biden Administration, which pushed for its increased use last April, doubling the number of locations to receive the pill, amid lingering supply issues. White House officials also lamented at the time it was being underused, even as those supply issues dissipated.
Further Reading
Weak Demand For Covid Antivirals Dampens Roaring Sales (Forbes)
Pharmacists Can Prescribe Pfizer’s Covid Antiviral Paxlovid, FDA Says (Forbes)
WHO Endorses Pfizer’s Antiviral Pill Paxlovid For High-Risk Covid Patients But Says Benefits ‘Trivial’ For Low-Risk Groups (Forbes)
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