The regulator said a formal plan for the clinical trial is expected to be finalized this month…reports Asian Lite News
The US Food and Drug Administration (FDA) has ordered Pfizer Inc. 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.