FDA Advisory Committee Votes Favoring Pfizer's COVID-19 Pill Paxlovid - Pfizer (NYSE:PFE)

The FDA's Antimicrobial Drugs Advisory Committee voted 16-1 that available data support the safety and effectiveness of Pfizer Inc's PFE Paxlovid for mild-to-moderate COVID-19 in adult patients who are at high risk for progression to severe illness.
Pfizer submitted a request to convert its EUA to full approval in June last year, but the FDA extended its review period by three months to consider additional data submitted, the company announced in December.
The current PDUFA action date for a decision by the FDA is May 2023.
The committee based its vote on the totality of scientific and real-world evidence shared by Pfizer, including safety and efficacy data from the EPIC clinical development program.
Compared to the placebo, the data showed an 86% reduction in risk of COVID-19-related hospitalization or death in Paxlovid-treated patients within five days of symptoms onset.
The vote was further supported by results from a secondary endpoint of the Phase 2/3 EPIC-SR study, which showed the effectiveness of Paxlovid in a sub-group of non-hospitalized adults with confirmed COVID-19 who had at least one risk factor for progression to severe disease and who were fully vaccinated.
Price Action: PFE shares are down 0.17% at $40.30 during the premarket session on the last check Friday.