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Sunday, October 25, 2026

Pfizer Seeks Emergency Use Authorization for Novel COVID-19 Oral Antiviral Candidate - Pfizer

  • If approved or authorized, PAXLOVID (PF-07321332; ritonavir) would be the first oral antiviral of its kind, a 3CL protease inhibitor specifically designed to combat SARS-CoV-2
  • EUA submission includes clinical data from an interim analysis of the Phase 2/3 EPIC-HR study, which demonstrated an 89% reduction in risk of COVID-19-related hospitalization or death compared to placebo in non-hospitalized high-risk adults with COVID-19
  • Rolling submissions have commenced in several countries including in the United Kingdom, Australia, New Zealand and South Korea, with planned submissions to other regulatory agencies around the world

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. today announced it is seeking Emergency Use Authorization (EUA) of its investigational oral antiviral candidate, PAXLOVID (PF-07321332; ritonavir), for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death. This submission to the U.S. Food and Drug Administration (FDA) includes clinical data from the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) interim analysis. Rolling submission of non-clinical data for PAXLOVID was initiated with the U.S. FDA in October 2021.

If authorized or approved, PAXLOVID would be the first oral antiviral of its kind, a 3CL protease inhibitor specifically designed to combat SARS-CoV-2 that could be prescribed as an at-home treatment to high-risk patients at the first sign of infection,...



Read Full Story: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-seeks-e...