Pfizer’s COVID drug data supports use in high-risk patients – FDA staff
March 14 (Reuters) – 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.
Our Standards: The Thomson Reuters Trust Principles.