The US Food and Drug Administration (FDA) has announced that it has approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of adult patients with mild-to-moderate COVID-19 if they are at high risk for progression to severe COVID-19, including hospitalisation or death.

The approval of Paxlovid marks the fourth approval of a drug to treat COVID-19 in adults, although this is the first oral antiviral pill to be approved for this indication.

The drug has previously been manufactured and packaged under the emergency use authorisation (EUA) and distributed by the US Department of Health and Human Services, and this will remain available in order to ensure that access remains consistent for adults, as well as for paediatric patients between 12 and 18 who are not covered by this approval.

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