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6 MWD=6-minute walk distance; AE=adverse event; ATTR-CM=transthyretin amyloid cardiomyopathy; CV=cardiovascular; GI=gastrointestinal;
KCCQ-OS=Kansas City Cardiomyopathy Questionnaire Overall Summary; TTR=transthyretin.
References: 1. Attruby. Prescribing information. BridgeBio, 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. Morfino P, Aimo A, Vergaro G, et al. Transthyretin stabilizers and seeding inhibitors as therapies for amyloid transthyretin cardiomyopathy. Pharmaceutics. 2023;15(4):1129. doi:10.3390/pharmaceutics15041129
4. 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
INDICATION
Attruby™ (acoramidis) is indicated for the treatment of 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 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.