Acoramidis approved in EU for treatment of ATTR-CM

17/02/2025

Acoramidis has been approved in the EU for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).

Acoramidis has been approved in the EU for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). The approval was based on positive results from the Phase III ATTRibute-CM study. This study showed that treatment with acoramidis had a beneficial effect on the hierarchical composite of all-cause mortality, CV hospitalization, change in HF severity or change in exercise tolerance in ATTR-CM patients compared to placebo. Overall, acoramidis was safe and well tolerated.

Transthyretin amyloid cardiomyopathy (ATTR-CM) is a progressive disease. It is characterized by the deposition of TTR amyloid, consisting of misfolded TTR aggregates, in the heart. Acoramidis has demonstrated near-complete (≥90%) stabilization of TTR, thereby minimizing amyloid formation.

Acoramidis will be launched in Europe in the first half of this year.

Source: Bayer press release, February 11, 2025

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