Data from Pfizer Inc’s trials of its COVID-19 drug support its use in adults at high-risk of the disease, staff reviewers at the U.S. Food and Drug Administration (FDA) said on Tuesday, with analyses not showing any clear association between the drug 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 to discuss a possible full approval of Pfizer’s oral pill Paxlovid, which has been cleared for emergency use since late 2021.
The comments follow multiple reports on COVID rebounds in some people after taking Paxlovid. President Joe Biden and Dr. Anthony Fauci, the then director of National Institute of Allergy and Infectious Diseases, both experienced a COVID rebound last year after taking the medicine.
However, during mid-to-late stage trials of the drug, overall rates of symptom rebound ranged from 10% to 16%, with no evidence of a higher rebound rate in patients who received the drug or the placebo, regardless of their risk to severe disease, or whether Omicron or an earlier variant was dominant, the reviewers said.
A full approval would allow Pfizer to market Paxlovid like other prescription medications.
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.