By Stephen Nakrosis

 

Pfizer, Inc. on Tuesday reported additional data on Paxlovid, which received emergency use authorization as a treatment for mild-to-moderate coronavirus disease in the U.S.

The company said in its EPIC-SR study of Paxlovid, or nirmatrelvir and ritonavir tablets, "the novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days was not met, as previously reported."

The company said in previously reported interim analyses it disclosed "the novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days was not met, and a non-significant 70% relative risk reduction was observed in the key secondary endpoint of hospitalization or death." Updated analysis from 1,153 patients enrolled through December 2021 showed a non-significant 51% relative risk reduction, Pfizer said. Also, "a sub-group analysis of 721 vaccinated adults with at least one risk factor for progression to severe Covid-19 showed a non-significant 57% relative risk reduction in hospitalization or death," according to Pfizer.

Pfizer also said additional analyses of secondary endpoint data showed treatment with Paxlovid "resulted in a nominally significant 62% decrease in Covid-19-related medical visits per day across all patients, relative to placebo."

Pfizer said it was ceasing enrollment into the EPIC-SR trial "due to low rate of hospitalization or death in the standard-risk population." Pfizer also said it will continue to "evaluate treatment in populations with high unmet need." The company will include available data in a planned new drug application submission to the U.S. Food and Drug Administration to support using Paxlovid "in appropriate individuals at high risk of progression to severe illness," it said.

Pfizer added that it will "focus efforts on generating further data on Paxlovid in vulnerable populations, including longer treatment durations in immunocompromised individuals, as well as exploring other clinical development opportunities."

 

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

 

(END) Dow Jones Newswires

June 14, 2022 17:27 ET (21:27 GMT)

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