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# J&J Seeks Stelara Expanded Use
- URL: https://www.fdaweb.com/j-j-seeks-stelara-expanded-use/
- Published: 2025-10-31T12:00:00.000Z
- Updated: 2026-09-14T15:25:30.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5160146

Johnson & Johnson has submitted a supplemental BLA seeking to expand the use of its biologic therapy Stelara (ustekinumab) to treat children aged two years and older with moderately to severely active ulcerative colitis (UC). The filing is based on data from the Phase 3 UNIFI Jr study, which evaluated the efficacy, safety, and pharmacokinetics of ustekinumab through 52 weeks in pediatric patients with UC.

Stelara, an interleukin-12 and -23 antagonist, is currently approved for treating adults with moderately to severely active Crohn’s disease and ulcerative colitis, as well as adults and children six years and older with active psoriatic arthritis and moderate to severe plaque psoriasis.

The company notes that it also submitted a similar application earlier this year seeking Stelara’s approval for pediatric Crohn’s disease in patients aged two years and older.

Ulcerative colitis, a chronic inflammatory bowel disease that affects more than one million people in the U.S., is increasingly diagnosed in children, who often experience more severe symptoms than adults, according to the company.