Article Author:
Reuters
The U.S. Food and Drug Administration (FDA) has asked Pfizer to test the effects of additional courses of the antiviral drug Paxlovid in people who have experienced a rebound of COVID-19 after treatment, the regulator said. officials said Friday.
Pharmaceutical companies must produce the first results of a randomized controlled trial of a second course of antiviral drugs by September 30 next year, the FDA said in his August 5 I sent a letter to Pfizer.
The directive follows reports from people including President Joe Biden and Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, of recurrences of viral infections and/or symptoms after the first course. I'm here.
Incidents Pfizer said were rare, prompting the FDA to begin discussions with the company about the trial in May.
Regulators said the study's protocol is expected to be completed this month.
Pfizer is "working with the FDA to finalize protocols for studying patients who may need retreatment," a company spokesperson said.
(Reporting by Leroy Leo, Bangalore; Editing by Aditya Soni)
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