The risk of hospitalization or death was reduced by 89 percent compared to placebo in non-hospitalized, high-risk adult patients with COVID-19 treated within three days of symptom onset.
On Tuesday, Pfizer said final results show that its novel COVID-19 oral antiviral tablets could reduce risk of hospitalization or death by close to 90 percent for high-risk patients.
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The results, based on an analysis of over 2,000 patients in a phase 2/3 trial, were consistent with the interim analysis announced in November 2021. The risk of hospitalization or death was reduced by 89 percent compared to placebo in non-hospitalized, high-risk adult patients with COVID-19 treated within three days of symptom onset, said Pfizer.
The treatment of patients by the oral antiviral pill within five days of symptom onset reduced risk of hospitalization or death by 88 percent up from 85 percent shown in the interim analysis. Pfizer has shared the final results with the U.S. Food and Drug Administration (FDA) as part of an ongoing rolling submission for emergency use authorization regarding the COVID-19 oral antiviral candidate.
"Emerging variants of concern, like Omicron, have exacerbated the need for accessible treatment options for those who contract the virus, and we are confident that, if authorized or approved, this potential treatment could be a critical tool to help quell the pandemic," said Albert Bourla, chairman and chief executive officer of Pfizer.
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Moreover, the oral antiviral pill reduced the risk of hospitalization by 70 percent in regards to standard-risk patients, according to interim analyses of another phase 2/3 trial by Pfizer.
The pill reduced viral load by approximately 10-fold at the fifth day of treatment compared with placebo in both the trials with high-risk and standard-risk patients.
On Nov. 30, an advisory panel to the FDA recommended the authorization of a COVID-19 antiviral pill, which is developed by Merck & Co, Inc. and Ridgeback Biotherapeutics LP with at least 30 percent of efficacy than a placebo at preventing hospitalizations and death from COVID-19 infections.
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