Pfizer submits NDA for COVID-19 treatment pills

Pfizer Inc. PFE said on Thursday that it submitted a New Drug Application NDA for COVID 19 treatment pills PAXLOVID for patients at high risk for serious illness. PAXLOVID was previously granted Emergency Use Authorization EUA for treatment of mild to moderate COVID - 19. The NDA submission provides longer-term follow-up data needed for potential approval, according to the drug maker. The data from our clinical development program, coupled with the more than 1.7 million patients worldwide 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 developing severe symptoms, regardless of vaccination status, said Pfizer Chief Executive Albert Bourla. The stock, which slipped by 0.6% in premarket trading, has lost 13.7% year to date through Wednesday, while the S&P 500 SPX has gone up 19.9%.