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Efficacy and Safety of Acoramidis in Transthyretin Amyloid Cardiomyopathy

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Efficacy and Safety of Acoramidis in Transthyretin Amyloid Cardiomyopathy

Gillmore JD, Judge DP, Cappelli F, et al. NEJM. 2024.

Results from ATTRibute-CM, a phase 3, double-blind, placebo-controlled study that evaluated the efficacy and safety of Attruby in patients with ATTR-CM.

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Efficacy of Acoramidis on All-Cause Mortality and Cardiovascular Hospitalization in Transthyretin Amyloid Cardiomyopathy

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Efficacy of Acoramidis on All-Cause Mortality and Cardiovascular Hospitalization in Transthyretin Amyloid Cardiomyopathy

Judge DP, Alexander KM, Cappelli F, et al. J Am Coll Cardiol. 2025.

This publication reports prespecified secondary and post hoc analyses from the ATTRibute-CM study to further characterize the efficacy of acoramidis on the clinical outcomes of ACM and CVH.

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Long-Term Efficacy and Safety of Acoramidis in ATTR-CM: Initial Report From the Open-Label Extension of the ATTRibute-CM Trial

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Long-Term Efficacy and Safety of Acoramidis in ATTR-CM: Initial Report From the Open-Label Extension of the ATTRibute-CM Trial

Judge DP, Gillmore JD, Alexander KM, et al. Circulation. 2025.

Results from an ongoing open-label extension study that was conducted to evaluate the long-term efficacy and safety of Attruby after 42 months of treatment.

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ATTR-CM: Then and Now

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ATTR-CM: Then and Now

Learn more about recent developments in disease state awareness and diagnostic approaches in ATTR-CM.

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Advances in ATTR-CM Imaging

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Advances in ATTR-CM Imaging

Learn more about cardiac imaging, a reliable, noninvasive, and relatively inexpensive method that can be used to help diagnose and monitor ATTR-CM.

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Unveiling ATTR-CM Among Patients with Common Cardiac Conditions

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Unveiling ATTR-CM Among Patients with Common Cardiac Conditions

Learn more about signs and symptoms of ATTR-CM, and how to recognize these clues to make a diagnosis.

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ACM=all-cause mortality; ATTR-CM=transthyretin amyloid cardiomyopathy; CVH=cardiovascular-related hospitalization.

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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.