Pfizer files for COVID-19 antiviral Paxlovid emergency use in USA

US pharma giant Pfizer (NYSE: PFE) said yesterday 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 US Food and Drug Administration includes clinical data from the Phase II/III 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 US 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, potentially helping patients avoid severe illness which can lead to hospitalization and death.