Pfizer Inc. $(PFE)$ said Thursday that it has submitted a New Drug Application (NDA) for COVID-19 treatment pills PAXLOVID for patients at high risk for progression to severe illness.
PAXLOVID has previously been granted Emergency Use Authorization $(EUA.UK)$ for treatment of mild-to-moderate COVID-19. The drug maker said the NDA submission provides longer-term follow-up data needed for potential approval.
"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," said Pfizer Chief Executive Albert Bourla.
The stock, which slipped 0.5% in premarket trading, has lost 13.7% year to date through Wednesday, while the S&P 500 has climbed 19.9%.
