For HCPs

About Attruby

Study Design

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

ATTRibute-CM: 30 months1,2

ATTRibute-CM study design showing inclusion and exclusion criteria and randomization to Attruby or placebo for 30 months

Concomitant use of tafamidis

was allowed after 12 months: 22.8% placebo vs 14.9% Attruby (acoramidis) patients (mean duration ~11 months)

Primary endpoint ⓘ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).1,2The Attruby USPI describes the primary endpoint as a 2-part composite that includes ACM and cumulative frequency of CVH over 30 months.1 was a hierarchical composite of1,2†:

ACM

Cumulative CVH frequency

CFB in NT-proBNP

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.1

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 assessments§.2,3

  • *Attruby (acoramidis) 712 mg twice daily is equivalent to Attruby (acoramidis) HCl 800 mg twice daily.3
  • †Analysis conducted using the stratified F-S test.2
  • ‡These secondary endpoints are prespecified and non-alpha protected.2 
  • §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 post-baseline efficacy evaluation and included participants who had a baseline eGFR <30 mL/min/1.73 m2.2

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

mITT Population Characteristics3 Attruby
(n=409)		 Placebo
(n=202)
Age, years
Mean (SD) 77.3 (6.5) 76.9 (6.8)
Sex, % (n)
Male 91.4% (374) 89.6% (181)
Female 8.6% (35) 10.4% (21)
TTR genotype, n(%)
ATTRv-CM 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)

||ie, NYHA Class I and II.3
IXRS stratification factors.2

OLE: 30-54 months

The open-label extension (OLE) trial is being conducted to collect and analyze long-term safety data in participants who completed the ATTRibute-CM trial.5

  • Participants who completed treatment at Month 30 were invited to enroll in the OLE5
  • Participants who previously received placebo were switched to Attruby (acoramidis), while treated patients continued on Attruby (acoramidis)5
  • Secondary objectives include continued monitoring of clinical outcomes (ACM, CVH, 6MWD, and KCCQ-OS)5
ATTRibute-CM study and open-label extension timeline through Month 54 showing treatment groups and participant enrollment.

No new safety concerns were observed in the OLE trial at Month 546

The OLE study is unblinded, non-controlled, and included a self-selected population which may have led to baseline imbalance; this non-prespecified, interim analysis was not powered to make definitive conclusions.6

  • *Attruby (acoramidis) 712 mg twice daily is equivalent to Attruby (acoramidis) HCl 800 mg twice daily.3

6MWD=6-minute walk distance; 99mTc=technetium labeled pyrophosphate (PYP) or bisphosphonate (eg, DPD); ACM=all-cause mortality; AF=atrial fibrillation; AL amyloidosis=light chain amyloidosis; ATTR=transthyretin amyloidosis; ATTR-CM=transthyretin amyloid cardiomyopathy; ATTRv=variant transthyretin-mediated amyloidosis; ATTRwt=transthyretin amyloidosis wild-type; BID=twice daily; 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; NAC=National Amyloidosis Centre; NT-proBNP=N-terminal pro–B-type natriuretic peptide; NYHA=New York Heart Association; OLE=open-label extension; SD=standard deviation; sTTR=serum transthyretin; 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 Pharma, Inc.;2024-2026.
  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. 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
  6. Soman P, Cuddy SAM, Gillmore JD, et al. Long-term durability of acoramidis efficacy in transthyretin amyloid cardiomyopathy: open-label extension of the ATTRibute-CM randomized clinical trial. JAMA Cardiol. 2026;11(5):446-454. doi:10.1001/jamacardio.2026.0819

Important Safety Information and Indication

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.

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.

Please see Full Prescribing Information including Patient Information.

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More information on DDIs1

Avoid concomitant use of Attruby (acoramidis) with UGT inducers and strong CYP3A inducers, as these can potentially decrease Attruby exposure.

Consider more frequent monitoring for evidence of increased exposure to CYP2C9 substrates when Attruby (acoramidis) is coadministered with sensitive CYP2C9 substrates.

CYP=cytochrome P450; DDI=drug-drug interaction; UGT=uridine diphosphate glucuronosyltransferase.

Established Safety Profile4

Patients With 1 or More Events Attruby
n=421, % (n)		 Placebo
n=211, % (n)
Any TEAEs 98.1% (413) 97.6% (206)
Any treatment-emergent SAEs 54.6% (230) 64.9% (137)
Any treatment-related TEAEs 11.9% (50) 5.2% (11)
Severe TEAEs 37.3% (157) 45.5% (96)

SAE=serious adverse event; TEAE=treatment-emergent adverse event.