Research & Development
Pfizer seeks full FDA approval of Paxlovid
30 June 2022 -

US biopharmaceutical company Pfizer Inc (NYSE:PFE) said on Thursday that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for full approval of its oral COVID-19 antiviral treatment, Paxlovid, for both vaccinated and unvaccinated individuals who are at high risk for progression to severe illness from COVID-19.

Paxlovid is currently authorised for emergency use for the treatment of mild-to-moderate COVID-19 in adults and children over 12 years of age who are at high risk for progression to severe COVID-19, including hospitalisation or death.

The NDA submission provides the longer-term follow-up data required for acceptance and potential approval.

Paxlovid is approved or authorised for conditional or emergency use in more than 65 countries worldwide to treat COVID-19 patients who are at increased risk for progressing to severe illness. As of the end of May 2022, Pfizer had shipped more than 12 million treatment courses of Paxlovid to nearly 40 countries.