FDA asks Pfizer to test second Paxlovid course in patients with COVID rebound
2022.08.19 23:42
FILE PHOTO: Paxlovid, Pfizer’s anti-viral medication to treat the coronavirus disease (COVID-19), is displayed in this picture illustration taken in Medford, Massachusetts, U.S., May 12, 2022. REUTERS/Brian Snyder/Illustration/
(Reuters) -The U.S. Food and Drug Administration (FDA) has ordered Pfizer Inc (NYSE:PFE) to test the effects of an additional course of its antiviral Paxlovid among people who experience a rebound in COVID-19 after treatment, the regulator said on Friday.
The drugmaker must produce initial results of a randomized controlled trial of a second course of the antiviral by Sept. 30 next year, the FDA told Pfizer in a letter dated Aug. 5.
The regulator said a formal plan for the clinical trial is expected to be finalized this month.
Pfizer is “working with the FDA to finalize a protocol to study patients who may be in need of retreatment,” and will provide details when available, a company spokesperson said.
