FDA Grants Full Approval to Pfizer's Paxlovid for High-Risk Adults -- Update
May 25 2023 - 11:33AM
Dow Jones News
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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