- 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.
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