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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.
