Regeneron Gets FDA Priority Review of Evinacumab
12 August 2020 - 10:01PM
Dow Jones News
By Colin Kellaher
Regeneron Pharmaceuticals Inc. on Wednesday said the U.S. Food
and Drug Administration granted priority review to its biologics
license application for evinacumab in patients with an ultra-rare
inherited form of high cholesterol.
The Tarrytown, N.Y., biotechnology company is seeking approval
of evinacumab as an adjunct to other lipid-lowering therapies in
patients with homozygous familial hypercholesterolemia.
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 to
six months from the standard 10 months. Regeneron said the agency
set a target action date of Feb. 11, 2021, for the application.
Regeneron said homozygous familial hypercholesterolemia affects
about 1,300 patients in the U.S., the vast majority of whom are
unable to reach target low-density lipoprotein cholesterol levels
with currently available therapies.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
August 12, 2020 07:46 ET (11:46 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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