Actor portrayals.
Actor portrayal.

Clinical Data

Attruby was proven to make an impact on survival, hospitalizations, and quality of life1,2*

*Defined as health-related quality of life and functional capacity.1

Secondary Endpoints
Primary Endpoint
Survival
Hospitalizations
KCCQ-OS/6MWD
Serum TTR
NT-proBNP
Select Endpoint
KCCQ-OS/6MWD icon

It's more than data. It's how they feel over time.

Attruby made a difference in health-related quality of life compared with placebo at 30 months1,2

Key Secondary Endpoint:
Change From Baseline in KCCQ-OS Score1

Table Table
Table
10
POINT
DIFFERENCE
(95% CI: 5.97-13.91; P<0.0001)†
More on Variant Subgroup

At 30 months, patients treated with
Attruby had better 6MWD results
than those who were not treated
with Attruby1

Key Secondary Endpoint:
Change From Baseline in 6MWD1

Table
Table
Difference
~131
feet
compared with placebo in
6MWD change from baseline
(95% CI: 69-190; P<0.0001)‡

†Some studies have shown that a mean 5-point change reflects a clinically meaningful change in health status.3

‡Equivalent to a difference of 40 meters. Analyzed using MMRM.4

6MWD=6-minute walk distance; KCCQ-OS=Kansas City Cardiomyopathy Questionnaire Overall Summary; LS mean=least-squares mean; MMRM=mixed model repeated measures.

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. 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 Cardiol. 2020;76(20): 2379-
2390. doi:10.1016/j.jacc.2020.09.542 4. Data on file. BridgeBio Pharma, Inc.; 2024-2025. 5. Fontana M, Kumar V, Sheridan P, et al. Descriptive analysis of unmet need
in a contemporary cohort of tafamidis-treated patients with ATTR-CM. Poster presented at: Heart Failure Society of America Annual Scientific Meeting;
September 27-30, 2024; Atlanta, GA.

Secondary Endpoints
Primary Endpoint
Survival
Hospitalizations
KCCQ-OS/6MWD
Serum TTR
NT-proBNP
Select an endpoint for more
Attruby data
KCCQ-OS/6MWD icon

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

Attruby was studied
in a contemporary
population that reflects
recent approaches in
diagnosis and care

See Study Design
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 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 ATTRibute-CM was a phase 3, randomized (2:1), double-blind, placebo-controlled study that assessed the efficacy (N=611) and safety (N=632) of Attruby in adults with hereditary or wild-type cardiac amyloidosis over 30 months.1,2 The win ratio was calculated to aid the interpretation of results from the F-S scoring algorithm to show the magnitude of effect between
Attruby and placebo. The stratified nonmatched win ratio method allocated all treated and placebo pairs within each stratum in the same hierarchical structure as the
F-S test.

In ATTRibute-CM, Attruby achieved a statistically significant
1.8 win ratio in the 4-component composite.2,5 Reductions in cardiovascular hospitalizations indicate better management of heart failure symptoms, leading to fewer acute episodes that require hospital care.3 The Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) is a patient-reported questionnaire designed to evaluate the impact of heart failure on a patient's physical and social functioning, as well as their symptoms and quality of life.3

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.