J&J's Janssen Gets European OK for Stelara in Ulcerative Colitis
September 04 2019 - 10:05AM
Dow Jones News
By Colin Kellaher
Johnson & Johnson's (JNJ) Janssen Pharmaceutical Cos. unit
on Wednesday said the European Commission approved the expanded use
of Stelara in adults with the inflammatory bowel disease ulcerative
colitis.
Janssen said the approval covers adults with moderately to
severely active ulcerative colitis who have had an inadequate
response with, lost response to, or were intolerant to either
conventional therapy or a biologic or have medical
contraindications to such therapies.
The European Medicines Agency's Committee for Medicinal Products
for Human Use in July recommended the expanded marketing
authorization of Stelara, which was approved in 2016 for the
inflammatory bowel disorder Crohn's disease.
The U.S. Food and Drug Administration is currently reviewing
Janssen's application for Stelara in adults with ulcerative
colitis.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 04, 2019 09:50 ET (13:50 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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