> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# BridgeBio Plans NDA for Cardiomyopathy Drug
- URL: https://www.fdaweb.com/bridgebio-plans-nda-for-cardiomyopathy-drug/
- Published: 2023-07-17T12:00:00.000Z
- Updated: 2026-09-14T18:44:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154889

BridgeBio Pharma says it plans to file an NDA by the end of the year after reporting “positive results” from ATTRibute-CM, a Phase 3 study of acoramidis in transthyretin amyloid cardiomyopathy, or ATTR-CM.

“ATTR-CM is an increasingly recognized cause of heart failure,” a company release says. The results from BridgeBio’s ATTRibute-CM trial showed an "81% on-treatment survival rate (versus a 74% survival rate on placebo), which begins to approach actuarial models of life expectancy absent ATTR-CM (85% in this population as has been documented),” it says. “The absolute risk reduction was 6.43% and the relative risk reduction was 25%.” Additionally, it says the study demonstrated a statistically significant relative risk reduction of 50% on frequency of cardiovascular-related hospitalization.

Bridgebio also says that no safety signals that have any “potential clinical concern” were identified.