BridgeBio Pharma (BBIO) announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization in the European Union for acoramidis 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. In the Phase 3 study ATTRibute-CM, acoramidis showed clear benefits on cardiovascular outcomes. The final approval decision, typically consistent with the CHMP recommendation, is expected from the European Commission in the coming months. Acoramidis was approved by the FDA on November 22, 2024 as Attruby, the first and only approved product for adults with ATTR-CM in the United States with a label specifying near-complete stabilization of TTR. The positive CHMP opinion for acoramidis is based on the positive ATTRibute-CM Phase 3 study results. The study investigated the efficacy and safety of acoramidis given twice daily compared with placebo, in subjects with ATTR-CM. The study met its primary clinical endpoints by significantly reducing cardiovascular-related hospitalization, improving survival, and preserving functional capacity and quality of life for patients in need. Since March 2024, BridgeBio and Bayer (BAYRY) have pursued a collaboration for acoramidis. BridgeBio holds the marketing rights for acoramidis in the U.S., while Bayer holds the marketing rights for the product in Europe. This partnership leverages Bayer’s long legacy of expertise in cardiovascular disease and its established European cardiovascular infrastructure paired with BridgeBio’s leadership in the emerging field of ATTR-CM. Pending European Commission approval, Bayer plans to launch acoramidis in Europe in the first half of 2025.
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