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Pfizer“s COVID drug data supports use in high-risk patients – FDA staff


Paxlovid, Pfizer’s anti-viral medication to treat the coronavirus disease (COVID-19), is displayed in this picture illustration taken October 7, 2022. A morning and an evening does consists of one white 100-milligram tablet of Ritonavir and two pink 150-milligram tablets of PF-07321332. REUTERS/Wolfgang Rattay/Illustration

The U.S. Food and Drug Administration’s staff reviewers said on Tuesday that data from Pfizer Inc’s (PFE.N) trials of its COVID-19 drug supports its use in adults at high-risk of the disease, ahead of a meeting of the agency’s experts to discuss full approval of the pill.

Reviewers also said that analyses conducted by the regulator and Pfizer did not identify a clear association between Paxlovid and a rebound in COVID symptoms seen among some patients.

The comments were made in the FDA’s briefing documents ahead of a meeting of the agency’s external advisers on Thursday.

A full approval would allow Pfizer to market Paxlovid like other prescription medications. The drug has been cleared for emergency use since late 2021.

The FDA in December extended its review of Paxlovid by three months after Pfizer submitted new analyses of data from the pill’s late-stage studies.

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