Thursday, 18 November 2021

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

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

Pfizer Inc 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.

admin Thu, 11/18/2021 - 15:51

source https://www.pharmatutor.org/pharma-news/2021/pfizer-seeks-emergency-use-authorization-for-novel-covid-19-oral-antiviral-candidate

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