Pfizer Gives Additional Data on Paxlovid, Ceasing Enrollment in EPIC-SR Study
June 14 2022 - 5:42PM
Dow Jones News
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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