BridgeBio Pharma: ATTRUBY (acoramidis)
FDA untitled letter, 9 September 2025. A direct-to-consumer TV ad for Attruby suggested patients could live carefree, return to life before their ATTR-CM diagnosis, and broadly improve their quality of life. FDA said trial data showed only a slower decline, not improvement.
The letter
- Date
- 9 September 2025
- Type
- Untitled letter (OPDP)
- Product
- ATTRUBY® (acoramidis) tablets (NDA 216540)
- FDA matter number
- MA 74
- Promoted piece
- Direct-to-consumer broadcast TV ad (MAT-US-ACO-0617)
- 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 20 November 2025, 72 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.
- Overstated or unsupported efficacy
“The totality of these claims and presentations also misleadingly suggests that treatment with Attruby will broadly improve a patient’s overall quality of life when this has not been demonstrated.”
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.