Pfizer said Nov. 5 its experimental COVID-19 antiviral pill reduced the risk of hospitalization or death by 89 percent in clinical trials, and the drugmaker plans to file for emergency use authorization from the FDA as soon as possible.
The drug, called Paxlovid, was given to non-hospitalized COVID-19 patients at high risk of progressing to severe illness and was most effective when given within three days of symptom onset. The results are based on a phase ⅔ study, in which there were no deaths in the group that received Paxlovid compared to 10 deaths in the placebo group.
Pfizer said it plans to submit an application for emergency use authorization of Paxlovid as soon as possible and will cease further enrollment of the study due to the overwhelming efficacy.
"Today's news is a real game-changer in the global efforts to halt the devastation of this pandemic. These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients' lives, reduce the severity of COVID-19 infections and eliminate up to nine out of ten hospitalizations," Albert Bourla, PhD, Pfizer's CEO, said in a news release.
Read Pfizer's full news release here.