For HCPs

Frequently
Asked
Questions (FAQs)

Actor portrayals.

About Attruby

What is Attruby indicated for and when was it approved?

Attruby (acoramidis) is a transthyretin (TTR) stabilizer 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. Attruby (acoramidis) was approved by the FDA in November 2024.1

View full Prescribing Information
How is Attruby administered?

Attruby (acoramidis) is administered orally using a fixed tablet regimen. The recommended dosage of Attruby is 712 mg twice daily taken whole with or without food. Do not cut, crush, or chew tablets.1

See full administration details

Diagnostics

How do you test for ATTR‑CM?

ATTR-CM is evaluated using a defined, stepwise diagnostic pathway. When clinical findings raise suspicion for cardiac amyloidosis, patients are screened for monoclonal protein to exclude AL amyloidosis. If AL is ruled out, cardiac scintigraphy (eg, Tc‑99m‑PYP or Tc-99m-HDP/HMDP*) can non-invasively confirm ATTR‑CM. Genetic testing is then recommended to differentiate wild‑type from hereditary disease.2-4

Watch video on Cardiac Imaging

*Not FDA-approved for the diagnosis of ATTR-CM.

What are the risks of delaying treatment in ATTR‑CM?

ATTR-CM is a progressive disease for which there is no known cure. Delaying treatment may allow further TTR destabilization, amyloid formation, and irreversible cardiac damage. As disease progresses, patients may experience worsening heart failure, increased hospitalizations, and higher mortality risk.5-7

Watch video on TTR

Mechanism of Action & TTR Stabilization

How does Attruby support
TTR stability?

ATTR-CM is caused by TTR destabilization, which contributes to amyloidogenesis, and subsequent disease progression. Increased TTR instability causes a decrease in TTR, which is associated with worse clinical outcomes.1,8

Attruby (acoramidis) is designed to deliver stabilization of the TTR tetramer by mimicking the properties of the naturally protective T119M variant. Attruby (acoramidis) stabilizes the TTR tetramer through enthalpy-driven formation of 2 hydrogen bonds in the T4 pocket, helping to address the underlying instability that leads to amyloid formation and cardiac damage.1,9-11

Explore the full Mechanism of Action
How quickly does Attruby show an effect on TTR?

Biochemical evidence of TTR stabilization can be identified early after treatment initiation using serum TTR as a measurable marker.12 In ATTRibute-CM, increases in serum TTR were observed as early as 4 weeks after initiating treatment with Attruby (acoramidis).12
These early changes provide a way to observe pharmacologic activity before clinical outcomes are assessed.9

See early serum TTR changes in Attruby
How can TTR stabilization be measured in clinical practice?

In clinical trials, TTR stabilization has been assessed using in vitro TTR stabilization assays and changes in serum TTR levels as pharmacodynamic markers to help characterize the biological activity of TTR stabilizers. In clinical practice, serum TTR can be used in addition to other clinical monitoring tools to assess the impact of TTR stabilizers.1,13

See early serum TTR changes in Attruby

Safety & Drug Interaction

What should I know about safety?

There was a higher frequency of gastrointestinal (GI) adverse reactions such as diarrhea 11.6% versus 7.6% and upper abdominal pain 5.5% versus 1.4% in the Attruby versus placebo group, respectively. The majority of these GI adverse reactions were categorized as mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were comparable between Attruby and placebo (9.3% and 8.5%, respectively).1,13

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 were 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.1

At Month 54 of the open-label extension study, no new safety concerns were observed.8

See detailed safety data
Are there any contraindications?

There are no contraindications for Attruby (acoramidis).1

What should I know about drug interactions?

No drug-drug interactions (DDIs) with statins (eg, rosuvastatin) per label.1

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 increase exposure to CYP2C9 substrates when Attruby (acoramidis) is coadministered with sensitive CYP2C9 substrates.

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

Access & Resources

If a health plan recommends an alternative therapy before approving coverage for Attruby, is the patient required to try it first?

Some plans may suggest an alternative therapy during the health insurance process. These recommended alternatives are not automatically required. If appropriate, you may provide supporting clinical rationale demonstrating why Attruby (acoramidis) is medically necessary for your patient.

See the ForgingBridges resource library
What should I do if Attruby is not listed on a patient's formulary?

For some patients, a formulary exception may be requested when supported by medical necessity. You may consider referring to the ForgingBridges Sample Letter of Medical Necessity to request Attruby (acoramidis) if a letter of medical necessity is required by your patient's health insurance plan.

For Medicare patients, you may reference the ForgingBridges Annotated Sample Coverage Determination Form. Coverage determination policies vary by plan. Your Field Reimbursement Manager (FRM) can help you understand available options and next steps.

See the ForgingBridges resource library
Can a patient still access Attruby after an initial denial?

Yes. An initial denial does not necessarily represent a final coverage decision. Depending on the circumstances, an appeal or formulary exception request may be successful when supported by appropriate clinical documentation and a treatment rationale that confirms the medical necessity and appropriateness of treatment with Attruby (acoramidis). You may consider referencing the ForgingBridges Sample Letter of Prior Authorization Denial Appeal.

Appeals should include the reason for denial, the patient’s clinical history, supporting clinical evidence, relevant laboratory and imaging results, treatment history, and any additional information demonstrating why Attruby (acoramidis) is medically necessary and the most appropriate treatment for your patient. Your FRM can support you, your office staff, and your patients through the treatment journey.

See available Access & Support services
Is there a free trial or starter option available for Attruby?

Yes, there is a one-month free trial available.
In certain situations, temporary access options may be available to help eligible patients begin therapy while coverage is being addressed. Details and eligibility considerations are outlined through dedicated access support programs.

Download the Free Trial Program Form to prescribe a 1-month supply of Attruby (acoramidis) at no cost. New Attruby (acoramidis) patients only.

Evidence & Outcomes

What types of patients were studied in the ATTRibute‑CM trial?

Attruby (acoramidis) is a transthyretin (TTR) stabilizer 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.
Attruby (acoramidis) was approved by the FDA in November 2024 for use across ATTR‑CM genotypes.1

See genotype‑specific data
What clinical outcomes were studied with Attruby?

Attruby (acoramidis) has been studied across outcomes in ATTR‑CM, including survival, cardiovascular hospitalizations, and measures of function and health-related quality of life.1,9

See complete study results
When was a difference observed in treatment with Attruby?

The primary composite endpoint included all-cause mortality (ACM) and cumulative frequency of cardiovascular-related hospitalizations (CVH) over 30 months, analyzed hierarchically using the stratified Finkelstein-Schoenfeld (F-S) test. The F-S test demonstrated a statistically significant reduction (P=0.018) in ACM and cumulative frequency of CVH in the ATTRUBY arm versus the placebo arm.1

In ATTRibute-CM, at month 3, a separation in Least Squares mean change from baseline in KCCQ-OS Score was observed between Attruby (acoramidis) and placebo. Both patients who received Attruby and patients on placebo experienced a decline in their KCCQ-OS. At Month 30, LS mean difference (95% CI) in change from baseline in KCCQ-OS was 10 points (95%Cl:5.97-13.91; P<0.0001)1*†

In clinical evaluation, differences between Attruby (acoramidis) and placebo in time to first event the composite of all-cause mortality and first cardiovascular hospitalization-were observed at 3 months.1

See time‑to‑first-event analyses

*Measured by KCCQ-OS score.
†Some studies have shown that a mean 5-point change reflects a clinically meaningful change in health status.14

Is there long‑term follow‑up data for Attruby?

Following the 30-month randomized, double-blind, placebo-controlled ATTRibute-CM study, an open-label extension (OLE) was available in which all participating patients received Attruby (acoramidis). This follow-up study was designed to evaluate the long-term safety of Attruby (acoramidis).14

See 54-month data

Special Populations

Is Attruby an appropriate treatment option for patients with mixed phenotype ATTR-CM (cardiac + neurologic manifestations)?

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.

Treatment effects were directionally consistent across both ATTRwt-CM and ATTRv-CM populations in subgroup analyses. These findings support use of Attruby (acoramidis) for ATTR-CM regardless of genotypes. Subgroup analyses were descriptive and exploratory in nature. Results were limited by small sample size.16

Attruby has not been studied or approved for use for PN.

See subgroup analysis

AL=light chain amyloidosis; ATTR-CM=transthyretin amyloid cardiomyopathy; ATTRv=variant transthyretin-mediated amyloidosis; ATTRwt=wild-type transthyretin-mediated amyloidosis; eGFR=estimated glomerular filtration rate; FDA=Food and Drug Administration; FRM=field reimbursement manager; HCP=hydroxydiphosphonate; HDMP=hydroxymethylene diphosphonate; KCCQ-OS=Kansas City Cardiomyopathy Questionnaire Overall Summary; NYHA=New York Heart Association; OLE=open-label extension; QoL=quality of life; TTR=transthyretin.

References:

  1. Attruby. Prescribing information. BridgeBio Pharma, Inc.; 2024.
  2. Kittleson MM, Ambardekar AV, Cheng RK, et al. Transthyretin cardiac amyloidosis evaluation and management: 2025 ACC concise clinical guidance. J Am Coll Cardiol. 2026;87(5):549-565. doi:10.1016/j.jacc.2025.09.004
  3. Hanna M, Ruberg FL, Maurer MS, et al. Cardiac scintigraphy with technetium-99m-labeled bone-seeking tracers for suspected amyloidosis: JACC review topic of the week. J Am Coll Cardiol. 2020;75(22):2851-2862. doi:10.1016/j.jacc.2020.04.022
  4. Witteles RM, Bokhari S, Damy T, et al. Screening for transthyretin amyloid cardiomyopathy in everyday practice. JACC Heart Fail. 2019;7(8):709-716. doi:10.1016/j.jchf.2019.04.010
  5. Kittleson MM, Maurer MS, Ambardekar AV, et al. Cardiac amyloidosis: evolving diagnosis and management: a scientific statement from the American Heart Association. Circulation. 2020;142(1):e7-e22. doi:10.1161/CIR.0000000000000792
  6. Stewart M, Shaffer S, Murphy B, et al. Characterizing the high disease burden of transthyretin amyloidosis for patients and caregivers. Neurol Ther. 2018;7(2):349-364. doi:10.1007/s40120-018-0106-z
  7. Lauppe R, Hansen JL, Fornwall A, et al. Prevalence, characteristics, and mortality of patients with transthyretin amyloid cardiomyopathy in the Nordic countries. ESC Heart Fail. 2022;9(4):2528-2537. doi:10.1002/ehf2.13961
  8. 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
  9. 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
  10. Miller M, Pal A, Albusairi W, et al. Enthalpy-driven stabilization of transthyretin by AG10 mimics a naturally occurring genetic variant that protects from transthyretin amyloidosis. J Med Chem. 2018;61(17):7862-7876. doi:10.1021/acs.jmedchem.8b00817
  11. Hammarström P, Jiang X, Hurshman AR, Powers ET, Kelly JW. Sequence-dependent denaturation energetics: a major determinant in amyloid disease diversity. Proc Natl Acad Sci USA. 2002;99(suppl 4):16427-16432. doi:10.1073/pnas.202495199
  12. Gertz MA, Aras MA, Bart N, et al. Unravelling the myriad physiologic roles of transthyretin: critical considerations for treating transthyretin amyloidosis. Ann Med. 2025;57(1):2536755. doi:10.1080/07853890.2025.253675
  13. Data on file. BridgeBio Pharma, Inc.; 2024-2026.
  14. Spertus JA, Jones PG, Sandhu AT, Arnold SV. Interpreting the Kansas City Cardiomyopathy Questionnaire in clinical trials and clinical care: JACC State-of-the-Art Review. J Am Coll Cordial. 2020;76(20):2379-2390. doi:70.7076/ j.jacc.2020.09.542
  15. 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
  16. Alexander KM, Davis MK, Akinboboye O, et al. Efficacy of acoramidis in wild-type and variant transthyretin amyloid cardiomyopathy: results from ATTRibute-CM and its open-label extension. JAMA Cardiol. 2026;11(1):57-67. doi:10.1001/jamacardio.2025.4477

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.

You’re about to leave AttrubyHCP.com and visit an external site. BridgeBio is not responsible for the content or privacy practices of the site you’re about to redirect to.

BridgeBio is committed to protecting and respecting your privacy. All information collected will be handled in accordance with our Privacy Policy. By clicking "Submit," you agree to share your contact information and certain health information with BridgeBio, BridgeBio affiliates, and companies working with BridgeBio or BridgeBio affiliates (collectively, "BridgeBio"). You agree that BridgeBio may contact you by mobile or online digital media, mail, email, fax, telephone call, and text messages (including autodialed and prerecorded calls and messages) for marketing purposes, including targeted online marketing, or to otherwise provide you with information about BridgeBio's products, treatment, or other offers. You can unsubscribe from these communications at any time by clicking "Unsubscribe" in the communications you receive.

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.