The EUA submission includes data from the company’s interim analysis of the Phase 2/3 EPIC-HR clinical trial.
Pfizer has announced that the company will be seeking FDA emergency use authorization (EUA) for PF-07321332/ritonavir (PAXLOVID), a first-of-its-kind oral antiviral treatment for mild to moderate COVID-19.
PAXLOVID is a 3CL protease inhibitor specifically designed to target the SARS-CoV-2 virus. The submission to the FDA includes data from an interim analysis of the Phase 2/3 EPIC-HR clinical trial (NCT04960202), initiated in July 2021. High-risk, non-hospitalized adults 18 and older (n=1219) with confirmed COVID-19 were enrolled in the trial and received either PAXLOVID or placebo.
Per the study results, those in the treatment group experienced an 89% reduction in the risk of COVID-19-related hospitalization or death from any cause when treatment was administered within 3 days of symptom onset; results were similar when treatment was administered within a 5-day window. Treatment-emergent adverse events were similar—19% and 21% in the treatment and placebo groups—and most were mild.
If authorized, PAXLOVID could be prescribed as an at-home treatment for high-risk patients at the first signs of infection.
“The overwhelming efficacy achieved in our recent clinical study of PAXLOVID, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19,” said Pfizer Chairman and CEO Albert Bourla in a press release.1 “We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients.”