FDA
Attruby (acoramidis) approved for ATTR cardiomyopathy
Brand name: Attruby
Generic name: acoramidis
Manufacturer: BridgeBio Pharma
Approval date: November 22, 2024
FDA approved Attruby (acoramidis), a near-complete (≥90%) stabilizer of transthyretin (TTR) for the treatment of adults with TTR amyloid cardiomyopathy (ATTR-CM) to reduce CV death and CV-related hospitalization.
Efficacy
According to a manufacturer press release, approval was based on data from the phase 3 ATTRibute-CM trial (NCT03860935), where Attruby significantly reduced death and CV-related hospitalization, and improved quality of life. The trial enrolled 632 participants with symptomatic ATTR-CM, associated with either wild-type or variant TTR. Participants were randomized 2:1 to receive Attruby or placebo for 30 months. The trial met its primary composite endpoint of all-cause mortality, CV hospitalization, change in NT-proBNP levels, and 6-minute walk distance.
Safety
In the ATTR-CM trial, there was a higher frequency of GI adverse reactions such as diarrhea (11.6% vs. 7.6%) and upper abdominal pain (5.5% vs. 1.4%) in the Attruby vs. placebo group, respectively. The majority of GI adverse reactions were mild and resolved without drug discontinuation.
Recommended dose
The recommended dosage of Attruby is 712 mg PO bid.
Sources:
BridgeBio Pharma. (2024, November 20). Attruby (acoramidis), a Near Complete TTR Stabilizer (≥90%), approved by FDA to Reduce Cardiovascular Death and Cardiovascular-related Hospitalization in ATTR-CM Patients. [Press release]. https://bridgebio.com/news/attruby-acoramidis-a-near-complete-ttr-stabilizer-%E2%89%A590-approved-by-fda-to-reduce-cardiovascular-death-and-cardiovascular-related-hospitalization-in-attr-cm-patients/
BridgeBio Pharma: Attruby (acoramidis) [Package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216540s000lbl.pdf
Gillmore JD, et al. (2024, January 10). N Engl J Med. Efficacy and Safety of Acoramidis in Transthyretin Amyloid Cardiomyopathy. https://pubmed.ncbi.nlm.nih.gov/38197816/