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# Pfizer Paxlovid NDA Approved for Covid
- URL: https://www.fdaweb.com/pfizer-paxlovid-nda-approved-for-covid/
- Published: 2023-05-25T12:00:00.000Z
- Updated: 2026-09-14T18:34:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154543

FDA has approved a Pfizer NDA for its antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets) for treating mild-to-moderate Covid-19 in adults who are at high risk for progression to severe disease, including hospitalization or death. Paxlovid was granted an emergency use authorization (EUA) 12/2021, which is still being maintained so that distribution by HHS can continue and to ensure continued access for adults and eligible children ages 12-18 who are not covered by the NDA approval, according to an [agency release](https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-antiviral-treatment-covid-19-adults?ref=fdaweb.com).

Approval was based on data from the EPIC-HR clinical trial that evaluated patients who had not received a Covid-19 vaccine and had not been previously infected. “Paxlovid significantly reduced the proportion of people with Covid-19-related hospitalization or death from any cause through 28 days of follow-up by 86% compared to placebo among patients treated within five days of symptom onset and who did not receive Covid-19 therapeutic monoclonal antibody treatment,” the agency says. “In this analysis, 977 patients received Paxlovid, and 989 patients received placebo, and among these patients, 0.9% who received Paxlovid were hospitalized due to COVID-19 or died from any cause during 28 days of follow-up compared to 6.5% of the patients who received the placebo.”