UCB: BIMZELX (bimekizumab-bkzx)
FDA untitled letter, 9 September 2025. A direct-to-consumer TV ad for Bimzelx suggested the drug improves emotional and social functioning in plaque psoriasis, which was not evaluated in its trials. Attention-grabbing visuals during the major statement also interfered with comprehension of the risk information.
The letter
- Date
- 9 September 2025
- Type
- Untitled letter (OPDP)
- Product
- BIMZELX® (bimekizumab-bkzx) injection, for subcutaneous use (BLA 761151)
- FDA matter number
- MA 310
- Promoted piece
- Direct-to-consumer TV ad 'Fade Cut'
- 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 6 January 2026, 119 days after the letter.
Read the letter on FDA.gov · Promoted material (PDF) · Close-out 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.
- Risk not clear and conspicuous
“some with frequent scene changes, during the presentation of the major statement interfere with comprehension of the major statement.”
- Overstated or unsupported efficacy
“The totality of these claims and representations misleadingly suggests that Bimzelx has a positive impact on one’s health-related quality of life (HRQoL).”
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.