Interim data from Pfizer Inc.’s novel COVID-19 antiviral candidate, PAXLOVID, revealed an oral treatment with the ability to cut the risk of hospitalization and death by as much as 89 percent among adult patients.
These results, pulled from the randomized Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) trial, compare the drug’s capabilities to that of placebo. As of the 28th day, no deaths were reported in patients who received PAXLOVID, unlike the 10 deaths among placebo-issued patients. Among patients given the drug within three days of symptom onset, only three of 389 recipients were hospitalized by day 28. Those given it within five days of symptom onset still escaped death, but six of 607 recipients were hospitalized from that group.
“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” Albert Bourla, chairman and CEO of Pfizer, said. “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.”
Building on this, Pfizer announced plans to submit this data as part of a rolling submission for an emergency use authorization (EUA) ongoing with the U.S. Food and Drug Administration.
Pfizer will cease further enrollment into the study due to the overwhelming efficacy demonstrated in these results and with regard to recommendations from an independent Data Monitoring Committee and the FDA. If approved or authorized by the FDA, PAXLOVID would be the first oral antiviral of its kind for COVID-19, and Pfizer plans to utilize it as an at-home treatment among adults.