Pfizer Halts Enrollment In Paxlovid COVID-19 Trial In Standard-Risk Population

  • Pfizer Inc PFE shared additional data from the Phase 2/3 EPIC-SR study of Paxlovid (nirmatrelvir and ritonavir tablets) in patients at standard risk for developing severe COVID-19. 
  • In previously reported interim analyses, the novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days was not met.
  • Non-significant 70% relative risk reduction was observed in the key secondary endpoint of hospitalization or death. 
  • Related: Pfizer, NIH Mulling Study For Longer Paxlovid Course To Combat Reinfections.
  • An updated analysis from 1,153 patients showed a non-significant 51% relative risk reduction. 
  • A sub-group analysis of 721 vaccinated adults with at least one risk factor for progression to severe COVID-19 showed a non-significant 57% relative risk reduction in hospitalization or death.
  • See Next: Read Why Pfizer Is Limiting Supply Of Paxlovid For Combination Studies: Bloomberg.
  • Pfizer said it would include the new data in the company's upcoming application to the FDA seeking full approval for the drug's use in high-risk groups.
  • Pfizer said it would halt enrollment in the EPIC-SR trial in standard-risk patients as the study revealed the treatment was ineffective in reducing symptoms in that group.
  • Price Action: PFE shares are up 0.56% at $48.19 during the premarket session on the last check Wednesday.
  • Photo via Wikimedia Commons

Posted In: BriefsCOVID-19 CoronavirusBiotechLarge CapNewsHealth CareGeneral

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