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# J&J Seeks Tremfya Crohn’s Indication
- URL: https://www.fdaweb.com/j-j-seeks-tremfya-crohns-indication/
- Published: 2024-06-20T12:00:00.000Z
- Updated: 2026-09-14T14:33:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157222

Johnson & Johnson has submitted an sBLA to FDA for approval of its Tremfya (guselkumab) to treat adults with moderately to severely active Crohn’s disease. A company [statement](https://www.google.com/url?sa=t&source=web&rct=j&opi=89978449&url=https://www.prnewswire.com/news-releases/johnson--johnson-submits-application-to-us-fda-seeking-approval-of-tremfya-guselkumab-for-the-treatment-of-moderately-to-severely-active-crohns-disease-302178478.html&ved=2ahUKEwi5waTkheuGAxUWEVkFHQksA2oQxfQBKAB6BAgLEAE&usg=AOvVaw1dB3pVFXiHLDQlCwSTMA4P) says that it also submitted an sBLA in March for an indication to treat severely active ulcerative colitis.

The Crohn’s disease application is supported by 48-week results from the Phase 3 GALAXI and GRAVITI studies, J&J says.

Tremfya is described as the first approved fully human, dual-acting monoclonal antibody that blocks interleukin-23, which is said to be an important driver of the pathogenesis of inflammatory diseases. It already is approved by FDA to treat specified adults with moderate to severe plaque psoriasis and adults with active psoriatic arthritis.