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Monkeypox: US Gov’t Leaders Say Tpoxx Needs Randomized Control Trial Before Treatment For All

 
• By Sarah Karlin-Smith

Media reports have emphasized the public’s frustration with gaining access to Tpoxx, an antiviral that may help treat monkeypox. But top officials at FDA, CDC and NIH defend the need to study the drug more first, even as they note they are making expanded access easier.

hand pulling paper out of jar
Federal officials say randomized research, not just expanded access, needed for potential monkeypox treatment • Source: shutter stock

Federal officials make the case for studying Tpoxx (tecovirimant) for monkeypox in randomized controlled trials in an opinion piece in the New England Journal of Medicine on 3 August, amidst clamor for the drug under expanded access and criticism of the hoops required to get the drug through that compassionate use process.

Authors of the NEJM piece, led by US Food and Drug Administration Office of Infectious Diseases Deputy Director Adam Sherwat,...

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More from United States

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• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.

More from North America

Infographic: Leqembi – A Geographical Comparison

 
• By Anabel Costa-Ferreira

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.

To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 
• By Sarah Karlin-Smith

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Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

 
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Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.