Pfizer COVID-19 Oral Antiviral Reduced Hospitalization Risk by 89%
Pfizer's investigational oral COVID-19 antiviral treatment candidate, PAXLOVID, significantly reduced hospitalization or death in high-risk adults. The company plans to submit data for Emergency Use Authorization in the U.S.
Pfizer Inc. announced significant results from an interim analysis of its Phase 2/3 EPIC-HR study for its investigational oral antiviral COVID-19 treatment candidate, PAXLOVID.
The study showed that PAXLOVID reduced the risk of COVID-19-related hospitalization or death by 89% compared to placebo in high-risk, non-hospitalized adults treated within three days of symptom onset. Through 28 days, 0.8% of patients receiving PAXLOVID were hospitalized, compared to 7.0% of those receiving placebo.
In the overall study population, no deaths were reported in patients who received PAXLOVID compared to 10 deaths in the placebo group. Based on these results, Pfizer, in consultation with the FDA, will cease further enrollment in the study.
The company plans to submit the data to the U.S. Food and Drug Administration (FDA) as part of its rolling submission for Emergency Use Authorization (EUA) as soon as possible. If authorized, PAXLOVID would be the first oral antiviral of its kind, a specifically designed SARS-CoV-2-3CL protease inhibitor.