For HCPs

About Attruby

Safety

Actor portrayals.

Demonstrated safety with no contraindications

In the ATTRibute-CM clinical trial1*:

Higher frequency of GI adverse reactions with Attruby (acoramidis) vs placebo

  • Diarrhea (11.6% vs 7.6%)
  • Upper abdominal pain (5.5% vs 1.4%)

Discontinuations due to adverse events were similar for Attruby (acoramidis) (9.3%) and placebo (8.5%)

No drug-drug interactions (DDIs) with statins (e.g., rosuvastatin) per label

No new safety concerns have been observed in the OLE trial at Month 542

*Based on ITT population (632 patients). 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 m2.3

DDI=drug-drug interaction; eGFR=estimated glomerular filtration rate; GI=gastrointestinal; ITT=intent-to-treat; OLE=open-label extension.

References:

  1. Attruby. Prescribing information. BridgeBio Pharma, Inc.; 2024.
  2. 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
  3. 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
  4. Gillmore JD, Judge DP, Cappelli F, et al. Efficacy and safety of acoramidis in transthyretin amyloid cardiomyopathy. N Engl J Med. 2024;390(2)(suppl 1):1-34. doi:10.1056/NEJMoa2305434

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.