Core Insights - Acoramidis has shown significant clinical benefits in reducing the incidence of atrial fibrillation (AF) and cardiovascular-related hospitalizations in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) [1][4][5] - The drug has received regulatory approvals in multiple regions, including the U.S. and Europe, indicating its potential as a treatment option for ATTR-CM [1][6] Group 1: Clinical Outcomes - In a post-hoc analysis of the ATTRibute-CM study, acoramidis reduced the annual frequency of cardiovascular hospitalizations (CVH) due to AF/atrial flutter (AFL) by 43% compared to placebo [1][4] - The incidence of new-onset AF/AFL was reduced by 17% in patients with no prior history of AF when treated with acoramidis [1][4] - A 42% reduction in composite all-cause mortality (ACM) and recurrent CVH events was observed at Month 30 relative to placebo [3] - Acoramidis treatment led to a greater than 50% reduction in ACM and CVH in participants with variant ATTR-CM compared to placebo [7] Group 2: Functional Capacity and Quality of Life - Patients with variant ATTR-CM treated with acoramidis showed a clinically significant slower decline in functional capacity and quality of life compared to placebo [7] - At Month 30, the mean difference in the 6-minute walk distance was 86.7 meters in favor of acoramidis (p = 0.0048) [7] - The KCCQ-OS score change from baseline at Month 30 was 20.3 points higher in the acoramidis group compared to placebo (p = 0.0019) [7] Group 3: Regulatory Approvals and Future Directions - Acoramidis is approved as Attruby™ by the U.S. FDA and as BEYONTTRA by the European Commission and other regulatory agencies [1][6] - The company plans to present more data on the benefits of acoramidis for ATTR-CM patients at future medical meetings [6]

Core Insights - The study of acoramidis in the ATTRibute-CM trial indicates that early and sustained increases in serum transthyretin (TTR) levels are associated with improved survival outcomes in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) [1][2][5] - Acoramidis, a near-complete TTR stabilizer, has shown significant clinical benefits, including reductions in all-cause mortality (ACM) and cardiovascular-related hospitalizations (CVH) [1][6][12] Group 1: Clinical Findings - A 5-mg/dL increase in serum TTR level within 28 days of treatment initiation correlates with a relative risk reduction of mortality of up to 31.6% through Month 30 [1][5] - The ATTRibute-CM study is the first to demonstrate a direct link between increased serum TTR and survival in ATTR-CM patients [1][2] - Acoramidis treatment resulted in a mean increase of 9.1 mg/dL in serum TTR levels within 28 days, which was sustained throughout the 30-month treatment period [5][6] Group 2: Statistical Outcomes - The study reported a 42% reduction in composite ACM and recurrent CVH events relative to placebo at Month 30 [4] - A 50% reduction in the cumulative frequency of CVH events was observed relative to placebo at Month 30 [4] - The analysis showed that the early increase in serum TTR levels was associated with reduced ACM, independent of baseline risk factors [5][6][12] Group 3: Regulatory Approvals - Acoramidis is approved as Attruby™ by the U.S. FDA and as BEYONTTRA by the European Commission, Japanese Pharmaceuticals and Medical Devices Agency, and UK Medicines and Healthcare Products Regulatory Agency [1][7] Group 4: Company Overview - BridgeBio Pharma, Inc. focuses on developing transformative medicines for genetic diseases and has a pipeline that includes advanced clinical trials [10]

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]