The U.S. health regulator's staff reviewers said on Tuesday data from Pfizer Inc's COVID-19 drug trials support its use in adults at high risk of progressing to severe disease, bringing the pill closer to a full approval.
The Food and Drug Administration made its assessment in briefing documents ahead of a meeting of the agency's external advisers on Thursday to discuss full approval to use Pfizer's oral pill for high-risk COVID-19 patients exhibiting mild to moderate symptoms.
The FDA's advisers will vote on whether the benefits related to Paxlovid outweigh its risks. The agency typically follows the advice of its expert advisers, but is not mandated to do so.
Paxlovid has been authorized for emergency use since late 2021, and a full approval is likely to allow Pfizer to expand its advertising campaign for the drug.
Over 12 million courses have been delivered to pharmacies, and patients have used over 8 million courses of the treatment, according to Federal data.
There have been multiple reports on COVID rebounds in some people after taking Paxlovid, including President Joe Biden and Dr Anthony Fauci, the then director of National Institute of Allergy and Infectious Diseases, last year.
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.
Dr Scott Dryden-Peterson, director of Mass General Brigham in Boston, said the data was the best evidence against COVID rebound, fears of which were limiting uptake, and the full approval would allow doctors flexibility in prescribing the drug.
Paxlovid has shown reduction in risk of hospitalization or death by 86% in non-hospitalized, high-risk adult patients in Pfizer' study, which did not include vaccinated participants.
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