Acoramidis Demonstrates Statistically Significant Reduction in Cardiovascular Mortality (CVM) through Month 42 of the ATTRibute-CM Open Label Extension

Core Insights - Acoramidis has shown a significant reduction in cardiovascular mortality (CVM) risk by 44% over 42 months post-randomization, establishing a new standard for outcomes in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) [1][2] - The treatment also demonstrated a 46% hazard reduction in the composite outcome of CVM or first cardiovascular hospitalization (CVH) over the same period [1] - Acoramidis has been approved by the U.S. FDA as Attruby and by the European Commission, Japanese Pharmaceuticals and Medical Devices Agency, and UK Medicines and Healthcare Products Regulatory Agency as BEYONTTRA [1][5] Efficacy and Clinical Benefits - In the ATTRibute-CM study, acoramidis exhibited the fastest benefit observed in any Phase 3 study for ATTR-CM, with significant improvements noted as early as 3 months [1] - At Month 30, there was a 42% reduction in composite all-cause mortality (ACM) and recurrent CVH events compared to placebo [1] - A 50% reduction in the cumulative frequency of CVH events was also reported at Month 30 relative to placebo [1] - Acoramidis treatment resulted in improved or stable NT-proBNP levels in approximately 50% of participants at Month 30, compared to fewer than 20% in the placebo group, indicating meaningful clinical improvement [3] - The treatment also showed a greater proportion of patients with stable or improved NAC Stage at Month 30 compared to placebo, suggesting better disease stabilization [3] Regulatory and Commercial Developments - BridgeBio Pharma has entered into an exclusive licensing agreement with Bayer Consumer Care AG for the commercialization of BEYONTTRA in Europe [4] - Future medical meetings are planned to present additional data on the benefits of Attruby for ATTR-CM patients [5]