Pfizer Seeks Complete Approval For Paxlovid For High Risk COVID-19 Patients

Pfizer Inc PFE has submitted a new drug application to the FDA for the approval of Paxlovid for patients at high risk for progression to severe illness from COVID-19.
Paxlovid is currently authorized for emergency use to treat mild-to-moderate COVID-19 in adults and pediatric patients at high risk for progression to severe COVID-19, including hospitalization or death.
The submission provides the longer-term follow-up data necessary for acceptance and potential approval.
Related: Pfizer Halts Enrollment In Paxlovid COVID-19 Trial In Standard-Risk Population.
According to the U.S. Centers for Disease Control and Prevention, 50-60% of the U.S. population is estimated to have one or more risk factors for progressing to severe COVID-19 illness.
The submission is supported by non-clinical and clinical data, including results from the Phase 2/3 EPIC-HR study in which Paxlovid reduced the risk of hospitalization or death by 88% compared to placebo.
An integrated analysis of data across the EPIC-HR and EPIC-SR studies showed an 84% reduction in hospitalizations or death compared to placebo and regardless of vaccination status.
Price Action: PFE shares are up 2.86% at $52.48 during the market session on the last check Thursday.