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Paxlovid Is First COVID-19 Rx Product To Get AdComm On Move From EUA To Full Approval

 
• By Brenda Sandburg

Approval seems assured, but US FDA advisory committee is forum for sharing evidence for use of Paxlovid in those infected with the Omicron variant and in immunocompromised individuals, as well as discussing the Pfizer product’s possible association with COVID-19 rebound.

Paxlovid
FDA advisory committee to review Pfizer's Paxlovid new drug application • Source: Shutterstock

The US Food and Drug Administration seems set to grant full approval to Pfizer Inc.’s Paxlovid COVID-19 treatment but it is seeking input from an advisory panel on the evidence for use of the oral antiviral in individuals infected with Omicron subvariants and in those who are immunocompromised, as well as Paxlovid’s association with COVID-19 rebound.

The FDA’s Antimicrobial Drugs Advisory Committee will consider Paxlovid’s new drug application on 16 March, and the meeting offers a...

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