BridgeBio announces EC marketing authorization for BETONTTRA

BridgeBio (BBIO) Pharma announced the European Commission has granted marketing authorization in the European Union for acoramidis, under the brand name BEYONTTRA for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy. Acoramidis is a selective small molecule, orally administered near-complete transthyretin stabilizer. ATTR-CM is a progressive fatal disease that presents as an infiltrative, restrictive cardiomyopathy resulting in heart failure. Bayer will be responsible for all commercial activity for acoramidis in the EU. The approval in the EU is based on results of the pivotal ATTRibute-CM Phase 3 study of acoramidis, which showed clear benefits on cardiovascular outcomes. ATTRibute-CM evaluated the efficacy and safety of acoramidis in 632 participants with symptomatic ATTR-CM, associated with either wild-type or variant TTR who were randomized 2:1 to receive acoramidis or placebo for 30 months. The study met its primary clinical endpoints at month 30 by significantly reducing cardiovascular-related hospitalization, improving survival, and preserving functional capacity and quality of life for patients in need.