Pfizer wins FDA panel vote for full approval of COVID pill
Joe Raedle
Update 3.30 PM EST: Adds remarks from Pfizer (NYSE:PFE)
- On Thursday, an independent advisory panel of the FDA endorsed Pfizer's (PFE) request to convert the emergency use authorization granted for its oral COVID therapy Paxlovid to a full approval.
- The FDA's Antimicrobial Drugs Advisory Committee met virtually on Thursday to discuss the company's marketing application for Paxlovid, submitted in June 2022.
- The panelists voted 16 – 1 on the question of if Paxlovid's overall benefit-risk profile is favorable when used to treat mild-to-moderate COVID-19 in adults at high risk of developing the severe form of the disease.
- The FDA usually follows AdCom recommendations before making a final decision on drug authorizations. A short while ago, Pfizer (PFE) announced the voting results, noting that the targeted action date for the FDA’s decision on Paxlovid is May 2023.
- Paxlovid, a combination of protease inhibitor nirmatrelvir and older antiviral ritonavir, was granted the FDA's emergency use authorization in 2021 to treat mild-to-moderate COVID-19 in at-risk individuals aged 12 years and above.
Read: Seeking Alpha contributor Nathan Aisenstadt projects additional demand for Paxlovid from a potential COVID spike in June-July 2023.