J&J Unit Files Esketamine NDA for Treatment-Resistant Depression
September 04 2018 - 9:26AM
Dow Jones News
By Colin Kellaher
Johnson & Johnson's (JNJ) Janssen Pharmaceutical Cos. unit
on Tuesday said it filed a new drug application with the U.S. Food
and Drug Administration for its esketamine nasal spray in
treatment-resistant depression in adults.
The drug maker said esketamine, if approved, would provide the
first new mechanism of action in 30 years to treat the mental
illness. Janssen said almost 300 million people suffer from major
depressive disorder worldwide, and about a third of them don't
respond to currently available treatments.
Janssen said the NDA is based on five pivotal Phase 3 studies
that showed treatment with esketamine nasal spray plus a newly
initiated oral antidepressant was associated with rapid reduction
of depressive symptoms and delayed time to relapse of symptoms of
depression.
The FDA previously granted breakthrough-therapy designations for
esketamine in treatment-resistant depression and in major
depressive disorder with imminent risk for suicide. Janssen said it
is currently conducting Phase 3 studies for the second
indication.
The company said it will seek European approval for the
esketamine treatment-resistant depression indication later this
year.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 04, 2018 09:11 ET (13:11 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
Johnson and Johnson (NYSE:JNJ)
Historical Stock Chart
From Mar 2024 to Apr 2024
Johnson and Johnson (NYSE:JNJ)
Historical Stock Chart
From Apr 2023 to Apr 2024
