Pfizer has announced on Friday that its experimental antiviral pill against COVID-19 reduced the risk of hospitalization or death by 89%.
The announcement was based on the result of their Phase 2/3 interim analysis of their EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) randomized, double-blind study of non-hospitalized adult patients with COVID-19, who are at high risk of progressing to severe illness.
Among the 389 patients who were given PAXLOVID™ (PF-07321332; ritonavir), a specifically designed SARS-CoV-2-3CL protease inhibitor, three days within the onset of symptoms, only 3 (0.8%) were hospitalized with no deaths, compared to the placebo group wherein out of the 385 patients, 27 were hospitalized and 7 succumbed to the disease.
Similar results were found for groups who were given the drug five days after symptom onset. Only 6 (1%) out of 607 patients were hospitalized, with zero deaths, compared to a 6% hospital and death rate for the placebo group.
“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,” said Pfizer Chairman and Chief Executive Officer Albert Bourla.
Due to the overwhelming efficacy of the drug, Pfizer will stop recruitment into the study and is now seeking to submit the data for Emergency Use Authorization from the US Food and Drug Administration (FDA) at the recommendation of an independent Data Monitoring Committee and in consultation with the FDA.
Companies are in the race for approval from the FDA to provide an at-home treatment for the coronavirus to help reduce illness severity, hospitalization, and death, as well as reinfection from exposure.
Merck and Co. have initially announced in October that their protease inhibitor antiviral pill Molnupiravir could reduce hospitalization and death in severe COVID-19 cases by 50%.