Tags: covid | paxlovid | pfizer | fda | advisers | approval | full

FDA Advisers Back Full Approval of Paxlovid

large white pill with "Paxlovid" on it
(Dreamstime)

Thursday, 16 March 2023 03:39 PM EDT

Advisers to the U.S. Food and Drug Administration on Thursday overwhelmingly backed Pfizer's oral antiviral COVID-19 treatment Paxlovid for full approval in adults at high risk of progression to severe disease.

The FDA's panel of outside experts voted 16-to-1 in favor of the drug's benefits outweighing its risk for some adults with mild-to-moderate COVID-19.

The agency typically follows the advice of its expert advisers, but is not required to do so.

Paxlovid has been authorized for emergency use in the U.S. in mild-to-moderate COVID patients aged 12 years and older since late 2021, but Pfizer's application for full approval only covers high-risk adults.

The regulator had earlier on Thursday said the current Paxlovid emergency use authorization (EUA) for high-risk adolescents will continue to remain in effect even if it receives full approval for use in older patients.

A full approval would provide doctors more flexibility in prescribing the drug and also allow the company to expand its advertising campaign.

© 2024 Thomson/Reuters. All rights reserved.


Health-News
Advisers to the U.S. Food and Drug Administration on Thursday overwhelmingly backed Pfizer's oral antiviral COVID-19 treatment Paxlovid for full approval in adults at high risk of progression to severe disease. The FDA's panel of outside experts voted 16-to-1 in favor of the...
covid, paxlovid, pfizer, fda, advisers, approval, full, recommendation, high-risk
159
2023-39-16
Thursday, 16 March 2023 03:39 PM
Newsmax Media, Inc.

Sign up for Newsmax’s Daily Newsletter

Receive breaking news and original analysis - sent right to your inbox.

(Optional for Local News)
Privacy: We never share your email address.
Join the Newsmax Community
Read and Post Comments
Please review Community Guidelines before posting a comment.
 
Find Your Condition
Get Newsmax Text Alerts
TOP

The information presented on this website is not intended as specific medical advice and is not a substitute for professional medical treatment or diagnosis. Read Newsmax Terms and Conditions of Service.

Newsmax, Moneynews, Newsmax Health, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc.

NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved
NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved