FDA advisers back Pfizer COVID treatment for full approval
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.
