FDA approves acoramidis for the treatment of ATTR-CM
02/12/2024
The FDA approves acoramidis, an oral TTR stabilizer, for the treatment of adults with ATTR-CM to reduce CV death and CV-related hospitalizations.
The FDA has approved acoramidis, an oral TTR stabilizer, for the treatment of adults with cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) to reduce CV death and CV-related hospitalizations. This decision was based on the results of the ATTRibute-CM Phase 3 study. This double-blind randomized trial showed that treatment with acoramidis resulted in a better four-step primary hierarchical outcome (which included death from any cause, CV-related hospitalization, the change from baseline in NT-proBNP level, and the change from baseline in the 6-minute walk distance) compared to placebo.
A Marketing Authorization Application has been submitted to the European Medicines Agency. A decision is expected in 2025.