The US Food and Drug Administration (FDA) has ordered Pfizer 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 last week.
The drugmaker must produce initial results of a randomised controlled trial of a second course of the antiviral by 30th September next year, the FDA told Pfizer in a letter dated 5th August.
The regulator said a formal plan for the clinical trial is expected to be finalised this month.
Pfizer is “working with the FDA to finalise a protocol to study patients who may be in need of retreatment,” and will provide details when available, a company spokesperson said.
Edits by EP News Bureau