Actor portrayals.

Study Design

ATTRibute-CM evaluated the impact of Attruby on mortality, hospitalization, and quality of life* over 30 months.1

ATTRibute-CM was a 30-month, prospective, multicenter, international,
randomized (2:1), double-blind, placebo-controlled study1,2

More on the open-label
extension (OLE) scheme scheme

Primary endpoint Tooltip was a
hierarchical composite of1,2‡:

Icon ACM
Icon Cumulative frequency
of CVH
Icon CFB in
NT-proBNP
Icon CFB in
6MWD

Efficacy assessment included 611 participants in the prespecified mITT population (eGFR ≥30 mL
/min/1.73 m2).
A total of 632 patients underwent randomization. Of these patients, 21 who had stage 4 CKD were excluded
from the primary analysis in the mITT population.2

Secondary endpoints included CFB in 6MWD, CFB in KCCQ-OS,
CFB in serum TTR, ACM, CVM,§ cumulative frequency of CVH,§
CFB in NT-proBNP,§ and safety assessments2,3||

Image Image

The proportion of patients in
earlier stages of disease reflects recent changes in disease
recognition and management2,4

mITT Population Characteristic3 Attruby
n=409 		Placebo
n=202
Age, years
Mean (standard deviation) 77.32 (6.474) 76.96 (6.739)
Sex, % (n)
Male 91.4% (374) 89.6% (181)
Female 8.6% (35) 10.4% (21)
TTR Genotype,# % (n)
ATTRv-CM Tooltip 9.5% (39) 9.9% (20)
ATTRwt-CM 90.5% (370) 90.1% (182)
NYHA Class, % (n)
NYHA Class I 12.5% (51) 8.4% (17)
NYHA Class II 70.4% (288) 77.2% (156)
NYHA Class III 17.1% (70) 14.4% (29)
eGFR (mL/min/1.73 m2), % (n)
>45 84.1% (344) 85.6% (173)
≤45 15.9% (65) 14.4% (29)

mITT Population Characteristic3

Attruby n=409

Placebo n=202

  • Age, years

    • Mean (standard deviation)

      77.32 (6.474)

      76.96 (6.739)

  • Sex, % (n)

    • Male

      91.4% (374)

      89.6% (181)

    • Female

      8.6% (35)

      10.4% (21)

  • TTR Genotype,# % (n)

    • ATTRv-CM Tooltip

      9.5% (39)

      9.9% (20)

    • ATTRwt-CM

      90.5% (370)

      90.1% (182)

  • NYHA Class, % (n)

    • NYHA Class I

      12.5% (51)

      8.4% (17)

    • NYHA Class II

      70.4% (288)

      77.2% (156)

    • NYHA Class III

      17.1% (70)

      14.4% (29)

  • eGFR (mL/min/1.73 m2), % (n)

    • ≥45

      84.1% (344)

      85.6% (173)

    • <45

      15.9% (65)

      14.4% (29)

list

Attruby was proven to make a positive impact in hospitalizations, quality of life*, survival, and more1,2

See Clinical Data
pill

Low rates of discontinuations due to adverse drug reactions and convenient dosing with Attruby1,5

See Dosing & Safety

*Defined as health-related quality of life and functional capacity.1

†Attruby 712 mg twice daily is equivalent to Attruby HCl 800 mg twice daily.3

‡Analysis conducted using the stratified F-S testTooltip.1

§These secondary endpoints are prespecified and non-alpha protected.3,6

||Based on ITT population of 632 patients, including 21 who had stage 4 CKD. The ITT population was defined as all randomized participants who received at least
1 dose of study drug and had at least 1 postbaseline efficacy evaluation and included participants who had a baseline eGFR <30 mL/min/1.73 m2.2

i.e., NYHA Class I and II.3

#IXRS stratification factors.2

6MWD=6-minute walk distance; 99mTc=technetium labeled pyrophosphate (PYP) or bisphosphonate (eg, DPD); ACM=all-cause mortality; AL amyloidosis=light chain amyloidosis; ATTR=transthyretin amyloidosis; ATTR-CM=transthyretin amyloid cardiomyopathy; ATTRv=variant transthyretin-mediated amyloidosis; ATTRwt=transthyretin amyloidosis wild-type; CFB=change from baseline; CKD=chronic kidney disease; CV=cardiovascular; CVH=cardiovascular-related hospitalization; CVM=cardiovascular-related mortality; eGFR=estimated glomerular filtration rate; F-S test=Finkelstein-Schoenfeld test; ITT=intent-to-treat; IXRS=Interactive Web Response Systems; KCCQ-OS=Kansas City Cardiomyopathy Questionnaire Overall Summary; mITT=modified intent-to-treat; NT-proBNP=N-terminal pro–B-type natriuretic peptide; NYHA=New York Heart Association; TTR=transthyretin; WT=wild-type.

References: 1. Attruby. Prescribing information. BridgeBio Pharma, Inc.; 2024. 2. Gillmore JD, Judge DP, Cappelli F, et al. Efficacy and safety of acoramidis in transthyretin amyloid cardiomyopathy. N Engl J Med. 2024;390(2):132-142. doi:10.1056/NEJMoa2305434 3. Data on file. BridgeBio, Inc.; 2024-2025. 4. Ioannou A, Patel RK, Razvi Y, et al. Impact of earlier diagnosis in cardiac ATTR amyloidosis over the course of 20 years. Circulation. 2022;146(22):1657-1670. doi:10.1161/
CIRCULATIONAHA. 122.060852 5. Gillmore JD, Judge DP, Cappelli F, et al. Efficacy and safety of acoramidis in transthyretin amyloid cardiomyopathy [study protocol]. N Engl J Med. 2024;390(2): 132-142. doi:10.1056/NEJMoa2305434 6. Judge DP, Gillmore JD, Alexander KM, et al. Long-term efficacy and safety of acoramidis in ATTR-CM: initial report from the open-label extension of the ATTRibute-CM trial. Circulation. 2025;151(9):601-611. doi:10.1161/CIRCULATIONAHA.124.072771 7. Judge DP, Gillmore JD, Alexander KM, et al. Long-term efficacy and safety of acoramidis in ATTR-CM: initial report from the open-label extension of the ATTRibute-CM trial. Circulation. 2025;151(9)(suppl 1):1-4. doi:10.1161/CIRCULATIONAHA.124.072771

The 4-step primary hierarchical composite endpoint evaluated in the ATTRibute-CM clinical trial included ACM, CVH, change from baseline in NT-proBNP, and change from baseline in 6MWD (assessed using the stratified F-S test).

The Attruby USPI describes the primary endpoint as a 2-part composite that includes ACM and cumulative frequency of CVH over 30 months.1,2 The F-S test is a statistical method based on the principle that each subject is compared to every other subject in each stratum in a pair-wise, hierarchical manner. ACM and cumulative CVH were considered to be the most clinically important components within the hierarchical endpoint and were appropriately the first and second components of
the hierarchy.

The F-S test results in a P value relating to the statistical significance of the difference noted between treatment and placebo groups but does not provide a magnitude of benefit. The magnitude of benefit is shown by the win ratio.5 62% of patients in the ATTRv-CM subgroup had the most prevalent US variant, V122I2

Indication and Important safety information

INDICATION

Attruby® (acoramidis) is indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.

IMPORTANT SAFETY INFORMATION

Adverse Reactions
Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation.

Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).

Laboratory Tests
Mean increase in serum creatinine of 0.2 and 0.0 mg/dL and a mean decrease in eGFR of 8.2 and 0.7 mL/min/1.73 m2 was observed in the adults with ATTR-CM treated with Attruby versus placebo, respectively, at Day 28 and then stabilized. These changes were reversible after treatment discontinuation.

Use in Specific Populations

Pregnancy & Lactation: There are no data on the use of Attruby in pregnant women. Animal data have not shown developmental risk associated with the use of Attruby in pregnancy. There are no available data on the presence of Attruby in either human or animal milk or the effects of the drug on the breastfed infant or maternal milk production.

Please see Full Prescribing Information including Patient Information.

INDICATION AND IMPORTANT
SAFETY INFORMATION

INDICATION

Attruby® (acoramidis) is indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.

IMPORTANT SAFETY INFORMATION

Adverse Reactions
Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation.

Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).

Laboratory Tests
Mean increase in serum creatinine of 0.2 and 0.0 mg/dL and a mean decrease in eGFR of 8.2 and 0.7 mL/min/1.73 m2 was observed in the adults with ATTR-CM treated with Attruby versus placebo, respectively, at Day 28 and then stabilized. These changes were reversible after treatment discontinuation.

Use in Specific Populations

Pregnancy & Lactation: There are no data on the use of Attruby in pregnant women. Animal data have not shown developmental risk associated with the use of Attruby in pregnancy. There are no available data on the presence of Attruby in either human or animal milk or the effects of the drug on the breastfed infant or maternal milk production.

Please see Full Prescribing Information including Patient Information.