FDA

Attruby (acoramidis) approved for ATTR cardiomyopathy

November 26, 2024

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/