Pfizer granted full FDA approval for COVID-19 pill
Jeenah Moon
The U.S. Food and Drug Administration (FDA) on Thursday issued full approval for Pfizer's (NYSE:PFE) oral COVID-19 therapy Paxlovid, as a treatment for the mild-to-moderate form of the disease in those who are at high risk of advancing to severe illness.
The decision comes more than two months after an independent advisory panel of the agency endorsed the full approval for the drug.
Paxlovid, a combination of protease inhibitor nirmatrelvir and older antiviral ritonavir, was granted emergency use authorization in late 2021 to treat mild-to-moderate COVID in at-risk people aged 12 years above.
After the FDA's Antimicrobial Drugs Advisory Committee voted 16 – 1, the FDA was expected to issue its final decision in May 2023. The treatment will continue to be available for the younger age group under the EUA.
"Today's approval demonstrates that Paxlovid has met the agency's rigorous standards for safety and effectiveness, and that it remains an important treatment option for people at high risk for progression to severe COVID-19," Director of the FDA’s Center for Drug Evaluation and Research Patrizia Cavazzoni said.