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Actor portrayals.

Study Design

The ATTRibute-CM study evaluated the impact
of Attruby on survival, hospitalization, and
health-related quality of life1,2

ATTRibute-CM was a prospective, multicenter, international,
randomized (2:1), double-blind, placebo-controlled study in
611 patients with ATTR-CM1,2*

scheme scheme

*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

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

The ATTRibute-CM study evaluated the impact of Attruby on mortality, hospitalization, and health-related quality of life over 30 months

Primary Endpoint info 1,2‡

was a hierarchical composite of:

  • ACM
  • Cumulative frequency of CVH
  • Change from baseline in NT-proBNP
  • Change from baseline in 6MWD

Secondary Endpoints2,3

were individual assessments of:

Key secondary endpoints

  • Change from baseline in 6MWD
  • Change from baseline in KCCQ-OS
  • Change from baseline in serum TTR
  • ACM

Other secondary endpoints

  • CVM§
  • Cumulative frequency of CVH§
  • Change from baseline in NT-proBNP§
  • Safety assessments||

Primary Endpoint info 1,2‡

was a hierarchical composite of:

  • ACM
  • Cumulative frequency of CVH
  • Change from baseline in NT-proBNP
  • Change from baseline in 6MWD

Secondary Endpoints2,3

were individual assessments of:

Key secondary endpoints

  • Change from baseline in 6MWD
  • Change from baseline in KCCQ-OS
  • Change from baseline in serum TTR
  • ACM

Other secondary endpoints

  • CVM§
  • Cumulative frequency of CVH§
  • Change from baseline in NT-proBNP§
  • Safety assessments||

‡Analysis conducted using the stratified F-S test info .1

§These secondary endpoints are prespecified and non-alpha protected.3,4

||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

Attruby was studied
in a contemporary
ATTR-CM population
that
reflects recent approaches
in diagnosis and care2,4

The proportion of trial participants
in the earlier stages of disease
reflects changes
in disease
recognition and management
in recent years2,4

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 9.5% (39) 9.9% (20)
ATTRwt 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 Characteristic5

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

      9.5% (39)

      9.9% (20)

    • ATTRwt

      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

More on Clinical Data
pill

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

More on Dosing & Safety

i.e., NYHA Class I and II.2

#IXRS stratification factors.3

6MWD=6-minute walk distance; 99mTc=technetium labeled pyrophosphate (PYP) or bisphosphonate (eg, DPD); ACM=all-cause mortality; AE=adverse event; AL amyloidosis=light chain amyloidosis; ATTR-CM=transthyretin amyloid cardiomyopathy; ATTRv=hereditary transthyretin-mediated amyloidosis; ATTRwt=transthyretin amyloidosis wild-type; 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; GI=gastrointestinal; 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, 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. 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

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

INDICATION

Attruby™ (acoramidis) is indicated for the treatment of 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 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.