J&J’s Janssen Gets European OK for Stelara in Ulcerative Colitis

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.

https://www.marketscreener.com/JOHNSON-JOHNSON-4832/news/Johnson-Johnson-J-J-s-Janssen-Gets-European-OK-for-Stelara-in-Ulcerative-Colitis-29157335/