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FDA advisers back Pfizer COVID treatment for full approval

2023-03-16T18:43:59Z

The Pfizer logo is pictured on their headquarters building in the Manhattan borough of New York City, New York, U.S., November 9, 2020. REUTERS/Carlo Allegri/

Advisers to the U.S. Food and Drug Administration on Thursday overwhelmingly backed Pfizer’s (PFE.N) 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.

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