Regeneron Cocktail Gets FDA Priority Review for Covid-19 Treatment, Prevention
October 14 2021 - 8:12AM
Dow Jones News
By Colin Kellaher
Regeneron Pharmaceuticals Inc. on Thursday said the U.S. Food
and Drug Administration granted priority review to its application
for its REGEN-COV antibody cocktail for the treatment and
prevention of Covid-19.
The Tarrytown, N.Y., biotechnology company said the application
covers the cocktail as a treatment of Covid-19 in non-hospitalized
patients and as prophylaxis in some individuals.
The FDA grants priority review to medicines that have the
potential to provide significant improvements in the treatment of a
serious disease, and the designation shortens the review
period.
Regeneron said the FDA set a target action date of April 13,
2022, and that the agency plans to hold an advisory committee
meeting to discuss the application.
Regeneron said its application is supported by a pair of Phase 3
studies involving more than 6,000 patients that evaluated the
efficacy and safety of REGEN-COV to treat non-hospitalized Covid-19
patients and to prevent symptomatic infection in asymptomatic
household contacts of infected individuals.
The company said it expects to file another application focusing
on the treatment of hospitalized patients later this year.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 14, 2021 07:57 ET (11:57 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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