Bridgebio Pharma Says Committee For Medicinal Products For Human Use (CHMP) Recommends Marketing Authorization In European Union For Acoramidis For The Treatment Of Wild-type Or Variant Transthyretin Amyloidosis In Adult Patients With Cardiomyopathy (ATTR-CM)

Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization in the European Union (EU) for acoramidis for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Acoramidis is a selective small molecule, orally administered near-complete (≥90%) transthyretin (TTR) stabilizer. ATTR-CM is a progressive fatal disease that presents as an infiltrative, restrictive cardiomyopathy resulting in heart failure. In the Phase 3 study ATTRibute-CM, acoramidis showed clear benefits on cardiovascular outcomes.