Earlier this month, Pfizer, the maker of Paxlovid, announced that it would stop adding new people to a clinical trial of the drug among COVID-19 patients who have a low risk of hospitalization and death. The study failed to show that the drug reduced symptoms, hospitalizations, or deaths in a statistically significant way, Bloomberg reported.
On Thursday, Pfizer announced the submission of a new drug application to the FDA for approval of Paxlovid for patients who are at high risk for severe COVID-19, hospitalization, or death. The submission provides longer-term follow-up data, which found that Paxlovid treatment reduced the risk of hospitalization or death by 88% in non-hospitalized, high-risk adults treated within 5 days of the start of symptoms.