Attruby FDA Approval History
Last updated by Judith Stewart, BPharm on Nov 25, 2024.
FDA Approved: Yes (First approved November 22, 2024)
Brand name: Attruby
Generic name: acoramidis
Dosage form: Tablets
Company: BridgeBio Pharma, Inc.
Treatment for: Cardiomyopathy of Transthyretin-Mediated Amyloidosis
Attruby (acoramidis) is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis in adults to reduce cardiovascular death and cardiovascular-related hospitalization.
- Cardiomyopathy of transthyretin-mediated amyloidosis (ATTR-CM) is a potentially fatal disease of the heart muscle characterized by accumulation of amyloid deposits, leading to cardiomyopathy and ultimately heart failure.
- Attruby was designed to mimic a naturally-occurring variant of the TTR gene (T119M), which provides instructions for making a protein called transthyretin (TTR). When TTR is destabilized (usually due to genetics or aging), it can build up to form amyloid deposits. By stabilizing TTR, Attruby has been shown to preserve the native function of TTR as a transport protein of thyroxine and vitamin A, and to demonstrate benefit on cardiovascular outcomes.
- FDA approval of Attruby was based on positive results seen in the ATTRibute-CM Phase 3 study, where Attruby demonstrated significant reductions in death and cardiovascular-related hospitalization, and improved quality of life.
- Attruby tablets are administered orally, twice daily.
- Common side effects include mild abdominal pain and diarrhea.
Development timeline for Attruby
Further information
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