About ATTR-CM
Without early intervention, ATTR-CM may lead to3,4:
- Earlier mortality
- Increased CV hospitalizations
- Significantly impaired quality of life
- Reduced functional capacity
For HCPs
For your patients with ATTR-CM,
Attruby significantly reduced the combination of ACM and CVH
at Month 30 (P =0.018, F-S test)1,2
About ATTR-CM
Without early intervention, ATTR-CM may lead to3,4:
Clinical results that make a real impact
Attruby was assessed in adults with hereditary or wild-type cardiac amyloidosis for efficacy (N=611) and safety (N=632) over 30 months in a phase 3, randomized (2:1), double-blind, placebo-controlled study. The primary endpoint was a 4-part hierarchical composite (ACM, CVH, CFB in NT-proBNP, CFB in 6MWD).1,2
At Month 30, Attruby (acoramidis) significantly reduced the combined outcome of ACM and CVH (P=0.018, F-S test).1,2
speed
In as early as 3 months, Attruby (acoramidis) showed a rapid observable difference in time to first event (ACM or CVH) vs placebo.1
strength
stability
>90% near-complete in vitro TTR stabilization.1,2
Discontinuations due to adverse events were similar for Attruby (acoramidis) (9.3%) and placebo (8.5%).1
6MWD=6-minute walk distance; ACM=all-cause mortality; ATTR-CM=transthyretin amyloid cardiomyopathy; CFB=change from baseline; CV=cardiovascular; CVH=cardiovascular-related hospitalization; F-S test=Finkelstein-Schoenfeld test; NT-proBNP=N-terminal pro–B-type natriuretic peptide; RRR=relative risk reduction; TTR=transthyretin.
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.
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.