Pfizer announces submission of New Drug Application to the US FDA for PAXLOVID™

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Tags:
  • Submission seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated individuals at high risk for progression to severe illness from COVID-19; consistent with current emergency use authorization
  • Final results from EPIC-HR study showed an 86% reduction in relative risk of hospitalizations or death from any cause; no deaths were observed in patients treated with PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) through Week 24, compared to 15 deaths observed with placebo
  • 50-60% of the U.S. population is estimated to have at least one risk factor for progressing to severe COVID-19 illness
  • Available safety data generally consistent in more than 3,500 PAXLOVID-treated participants across EPIC clinical development program

Read the full press release here.

 

Source : Pfizer

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