Product Code Database
Acoramidis, sold under the brand name Attruby, is a medication used for the treatment of cardiomyopathy. It is a near-complete (>90%) transthyretin stabilizer, developed to mimic the protective properties of the naturally occurring T119M mutation, to treat transthyretin amyloid cardiomyopathy. It is taken by mouth.
The most common adverse reactions include diarrhea and upper abdominal pain.
Acoramidis was approved for medical use in the United States in November 2024, and in the European Union in February 2025.
Phase II and the Open-Label Extension (OLE) data indicated after a median of 38 months, long-term treatment with acoramidis was generally well tolerated and resulted in a median decline in NT-proBNP levels, normalization of serum TTR, and sustained stabilization of TTR in individuals with ATTR-CM.
Phase III data from ATTRibute-CM indicated acoramidis resulted in a significantly better four-step primary hierarchical outcome containing components of mortality, morbidity, and function than placebo at 30 months in participants with ATTR-CM. Adverse events were similar in the two groups.
Other analyses from ATTRibute-CM indicated a 50% reduction in cumulative cardiovascular hospitalizations (CVH), a 42% reduction in all-cause mortality (ACM) and recurrent CVH, and a 3-month time-to-separation of the Kaplan Meier curves for ACM or CVH. No other treatment has demonstrated this degree of treatment effect this quickly in participants with ATTR-CM.
In vitro data indicated acoramidis exhibits near-complete (>90%) TTR stabilization at therapeutic trough concentrations, and its TTR stabilization exceeds that of tafamidis' across a range of destabilizing TTR mutations.
In December 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Beyonttra, intended for the treatment of transthyretin amyloidosis in adults with cardiomyopathy. The applicant for this medicinal product is BridgeBio Europe B.V. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Acoramidis was designated an orphan medicine by the EMA. Acoramidis was authorized for medical use in the European Union in February 2025.
Acoramidis is the international nonproprietary name.
Acoramidis is sold under the brand names Attruby and Beyonttra.
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