Johnson & Johnson: TREMFYA (guselkumab)
FDA untitled letter, 6 February 2026. A direct-to-consumer TV ad for Tremfya in ulcerative colitis overstated remission, endoscopic remission and healing results from selected patient subsets. It also left the infection risk warning out of the major statement.
The letter
- Date
- 6 February 2026
- Type
- Untitled letter (OPDP)
- Product
- TREMFYA® (guselkumab) injection, for subcutaneous or intravenous use (BLA 761061)
- FDA matter number
- MA 1242
- Promoted piece
- DTC TV ad 'TREMFYA DTC UC TVC SubQ Endcard'
- Aimed at
- Consumers (DTC)
- Format
- TV ad
- Came in under Form FDA 2253
- Yes, the letter says it was submitted on Form FDA 2253
- Close-out
- FDA closed the matter out on 17 June 2026, 131 days after the letter.
What FDA cited
The categories below are this tool's labels, read from the letter. Each quote is FDA's own wording, copied from the letter.
- Omits or minimizes risk
“The TV ad is also misleading because it includes claims and presentations about the uses and benefits of Tremfya but omits material risk information”
- Overstated or unsupported efficacy
“These claims misleadingly overstate the efficacy of Tremfya by suggesting that Tremfya has been shown to have a curative effect in patients with moderately to severely active ulcerative colitis”
Check your claims before FDA does
Arca reads a promotional piece against the approved labeling and the references it cites, and flags each claim the label does not support. See how Arca supports MLR review. Back to the OPDP letter search.