First Oral Antiviral Is Approved for Adults With Mild to Moderate COVID-19

Paxlovid is the first oral antiviral to be approved by the US Food and Drug Administration for the treatment of adults with mild to moderate COVID-19.¹

Three other medications are approved for treating this population, but none are administered orally. Paxlovid is not intended or approved to be used as pre- or post-exposure prophylaxis.

The approval comes after a multitude of positive results from the EPIC-HR² and EPIC-SR³ trials.

“While the pandemic has been challenging for all of us, we have made great progress mitigating the impact of COVID-19 on our lives,” said Patrizia Cavazzoni, MD, director for the FDA’s Center for Drug Evaluation and Research, via FDA press release.¹

“Today’s approval demonstrates that Paxlovid has met the agency’s rigorous standards for safety and effectiveness, and that it remains an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity. The FDA remains committed to working with sponsors to facilitate the development of new prevention and treatment options for COVID-19.” 

References:

1. FDA approves first oral antiviral for treatment of COVID-19 in adults. Press Release. US Food and Drug Administration. May 25, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-antiviral-treatment-covid-19-adults
2. Hammond J, Leister-Tebbe H, Gardner A, et al; for the EPIC-HR Investigators. Oral nirmatrelvir for high-risk, nonhospitalized adults with covid-19. N Engl J Med. 2022;386:1397-1408. doi:10.1056/NEJMoa2118542
3. Pfizer. Evaluation of protease inhibition for covid-19 in standard-risk patients (EPIC-SR). NCT05011513. Posted December 12, 2022. Accessed May 25, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT05011513