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
Hospitalizations icon

Less time in the hospital. More time to keep life in motion.

Attruby reduced the annual frequency of CVH events by approximately half1
50%RRR The mean number of CVH events was 0.3 per year
for Attruby-treated patients compared with 0.6 per year
for placebo1 More on Variant
Subgroup
50
% RRR2

The mean number of CVH events was 0.3 per year for Attruby-treated patients compared with 0.6 per year for placebo1

More on Variant Subgroup
golf game Actor portrayals.

CVH=cardiovascular-related hospitalization; RRR=relative risk reduction.

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. 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

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