Pfizer announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of PAXLOVID (nirmatrelvir and ritonavir tablets) for patients who are at high risk for progression to severe illness from COVID-19.

PAXLOVID is currently authorized for emergency use for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. The submission provides the longer-term follow-up data necessary for acceptance and potential approval.

“As the COVID-19 pandemic continues to evolve and be highly unpredictable, we must remain vigilant in protecting those who are at greatest risk of getting very sick from COVID-19, as they remain vulnerable to potential hospitalization or even death,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Data from our clinical development program, coupled with the more than 1.7 million patients around the world who have been prescribed our oral treatment to date, reinforce PAXLOVID as an important treatment option for mild-to-moderate COVID-19 in patients at greater risk of progression to severe symptoms, regardless of vaccination status. We look forward to working with the FDA toward full regulatory approval for PAXLOVID.”

PAXLOVID is currently approved or authorized for conditional or emergency use in more than 65 countries across the globe 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 around the world.