PFE Pfizer Inc

By Colin Kellaher

The U.S. Food and Drug Administration has granted full approval to Pfizer's Paxlovid for high-risk adults, paving the way for the drugmaker to sell the oral antiviral commercially.

The FDA on Thursday said the green light covers Paxlovid for the treatment of mild-to-moderate Covid-19 in adults who are at high risk for progression to a severe case, including hospitalization or death.

New York-based Pfizer has been selling Paxlovid to the federal government under an emergency-use authorization granted in late 2021, with the government then directing distribution.

The full FDA nod gives Pfizer the ability to sell the drug as it does most of its medicines -- with the help of advertising and through intermediaries that distribute it to pharmacies and other buyers.

Pfizer on Thursday said the U.S. government would continue to oversee the distribution of Paxlovid at this time, with U.S. residents eligible for the drug would continue to receive it at no charge.

The company said Paxlovid also remains available for eligible children ages 12 and up under the emergency-use authorization, and that it continues to gather pediatric data from an ongoing clinical trial, with the aim of seeking FDA approval of Paxlovid in children at a future date.

Paxlovid is the first oral antiviral pill and the fourth drug overall that the FDA has approved to treat Covid-19 in adults.

Pfizer earlier this month said it expects Paxlovid revenue of about $8 billion this year, down 58% from 2022 levels, as the Covid-19 pandemic ebbs and demand wanes for the pill and the Covid-19 vaccine Comirnaty, which Pfizer developed with BioNTech.

The company said more than 11.6 million treatment courses of Paxlovid have been prescribed in the U.S. to date.

-Jared S. Hopkins contributed to this article

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

May 25, 2023 12:18 ET (16:18 GMT)

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