New Drug Application Submitted for Oral COVID-19 Treatment

New York-based Pfizer Inc. announced today the submission of a New Drug Application (NDA) to the U.S. FDA for approval of PAXLOVID™ for patients at high risk for progression to severe illness from COVID-19.

Pfizer stated on June 30, 2022; it seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated individuals.

Albert Bourla, Chairman and Chief Executive Officer, Pfizer, commented in a released press release, "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."

PAXLOVID is currently authorized for emergency use to treat mild-to-moderate COVID-19 in adults and certain pediatric patients with positive results of direct SARS-CoV-2 coronavirus viral testing and at high risk for progression to severe COVID-19.

Available safety data for PAXLOVID have generally been consistent in more than 3,500 PAXLOVID-treated participants.

Data from various studies showed a consistent reduction in viral load with PAXLOVID, including across both the Delta and Omicron variants.

And that the frequency of return of detectable nasal viral RNA following PAXLOVID treatment was low and generally similar among PAXLOVID and placebo recipients.

PAXLOVID is currently approved or authorized for conditional or emergency use in more than 65 countries worldwide.

As of May 2022, Pfizer shipped more than 12 million treatment courses of PAXLOVID to nearly 40 countries globally.

Note: This Pfizer media release was manually curated for mobile readers.