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/
Aug 19 (Reuters) – The U.S. Food and Drug Administration (FDA) has asked Pfizer Inc (PFE.N) 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 the initial results of a randomized controlled trial of a second course of the antiviral by Sep. 30 next year, the FDA told Pfizer in a letter dated Aug. 5.
The directive follows reports of recurrent viral infection or symptoms, or both, after the first course, including in President Joe Biden and National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci. read more
The incidents, which Pfizer says are rare, prompted the FDA to start talks with the company about the trial in May. read more
The regulator said a protocol for the study 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.
Our Standards: The Thomson Reuters Trust Principles.
A manufacturer of mifepristone, a drug used in medication abortions, on Thursday dropped its legal fight to sell the drug in Mississippi after the state banned nearly all abortions.
Reuters, the news and media division of Thomson Reuters, is the world’s largest multimedia news provider, reaching billions of people worldwide every day. Reuters provides business, financial, national and international news to professionals via desktop terminals, the world's media organizations, industry events and directly to consumers.
Build the strongest argument relying on authoritative content, attorney-editor expertise, and industry defining technology.
The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs.
The industry leader for online information for tax, accounting and finance professionals.
Access unmatched financial data, news and content in a highly-customised workflow experience on desktop, web and mobile.
Browse an unrivalled portfolio of real-time and historical market data and insights from worldwide sources and experts.
Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks.
All quotes delayed a minimum of 15 minutes. See here for a complete list of exchanges and delays.
© 2022 Reuters. All rights reserved
