J&J's Janssen Gets CHMP Positive Opinion for Stelara in Ulcerative Colitis

By Colin Kellaher

Johnson & Johnson's (JNJ) Janssen Pharmaceutical Cos. unit on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended marketing authorization of Stelara in adults with the inflammatory disease ulcerative colitis.

Janssen said the CHMP positive opinion covers the use of use of Stelara for the treatment of 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 company said there is currently no cure for ulcerative colitis, a chronic immune-mediated inflammatory disease of the large intestine that affects 2.6 million people in Europe.

Janssen said it expects a final decision from the European Commission later this year. The commission generally follows the CHMP's recommendations.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

July 26, 2019 07:54 ET (11:54 GMT)

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