BEYONTTRA® (acoramidis), the First Near-complete TTR Stabilizer (≥90%), Approved by the UK Medicines and Healthcare Products Regulatory Agency to Treat ATTR-CM

Core Insights - The UK has granted marketing authorization for acoramidis, branded as BEYONTTRA, for treating wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM) [1][2] - Acoramidis is the first and only approved treatment for ATTR-CM in the U.S., EU, UK, and Japan, with a label specifying near-complete stabilization (≥90%) of transthyretin (TTR) [1][3] - The approval is based on positive results from the Phase 3 ATTRibute-CM study, which demonstrated significant cardiovascular benefits [2][3] Summary by Category Product Approval - The Medicines and Healthcare products Regulatory Agency in the UK has approved acoramidis for ATTR-CM treatment [1][2] - Acoramidis has previously received approvals in the U.S. as Attruby™ and in the EU and Japan as BEYONTTRA [3] Clinical Study Results - The ATTRibute-CM study involved 632 participants and showed a 42% reduction in composite all-cause mortality and recurrent cardiovascular-related hospitalization events at Month 30 compared to placebo [1][2] - A 50% reduction in the cumulative frequency of cardiovascular-related hospitalization events was also observed at Month 30 [1] Market and Financial Aspects - BridgeBio will receive royalties in a tiered structure starting in the low-thirties percent on sales of BEYONTTRA in the UK [1][4][5] - Bayer is responsible for all commercial activities related to acoramidis in the UK [1][3]