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Transthyretin amyloid cardiomyopathy (ATTR-CM)
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Acoramidis Demonstrates Statistically Significant Reduction in Cardiovascular Mortality (CVM) through Month 42 of the ATTRibute-CM Open Label Extension
Globenewswire· 2025-08-30 11:15
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]
Early and Sustained Increase in Serum TTR Levels by Acoramidis Independently Predicted Improved Survival in the ATTRibute-CM Study
Globenewswire· 2025-05-19 16:33
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]
BridgeBio to Present Clinical Outcomes, Quality of Life Measures and Incidence of Atrial Fibrillation Events in Patients with ATTR-CM from the ATTRibute-CM Study at the Annual Congress of the Heart Failure Association of the ESC
GlobeNewswire News Room· 2025-05-12 11:30
Core Insights - BridgeBio Pharma, Inc. announced the presentation of clinical outcomes and quality of life measures related to acoramidis for treating variant transthyretin amyloid cardiomyopathy (ATTR-CM) at the Heart Failure 2025 Congress in Belgrade, Serbia from May 17-20, 2025 [1][2] Group 1: Clinical Presentations - A rapid-fire abstract will present results showing that acoramidis improves serum TTR levels in patients with wild-type or variant ATTR-CM [3] - Two moderated ePosters will discuss the effect of acoramidis on functional capacity and quality of life, as well as its impact on all-cause mortality, cardiovascular hospitalization, and NT-proBNP levels in patients with variant ATTR-CM [3] - A post-hoc analysis will be presented indicating that acoramidis treatment is associated with a lower incidence of atrial fibrillation-related events in patients with ATTR-CM [3] Group 2: Real-World Data - Three moderated ePosters will cover disease progression of ATTR-CM in a real-world setting, a retrospective cohort study on the time from manifestation to diagnosis, and data on the causes of death in ATTR-CM patients [2][4] Group 3: Product Information - Attruby (acoramidis) is indicated for treating the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults, aiming to reduce cardiovascular death and related hospitalizations [5] - Adverse reactions reported include diarrhea (11.6% vs 7.6% in placebo) and upper abdominal pain (5.5% vs 1.4% in placebo), with most being mild and resolving without drug discontinuation [6][7] Group 4: Company Overview - BridgeBio Pharma is focused on discovering, creating, testing, and delivering transformative medicines for genetic diseases, with a pipeline ranging from early science to advanced clinical trials [8]