FDA grants full approval for first oral antiviral for COVID-19 in adults

Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.

Developed by US pharma giant Pfizer (NYSE: PFE), Paxlovid is the fourth drug - and first oral antiviral pill - approved by the FDA to treat COVID-19 in adults.

Paxlovid has been available in the USA since December 2021 under Emergency Use Authorization (EUA), and the overall benefit/risk profile and indication for use in eligible adults remain consistent with the EUA. More than 11.6 million treatment courses of Paxlovid have been prescribed in the USA to date, according to Pfizer.