Open-Label Extension Data Confirms Sustained Benefit of Acoramidis on Cardiovascular Outcomes, Including Statistically Significant Reduction in ACM Within 36 Months

Core Insights - Acoramidis shows significant early and sustained clinical benefits in patients with ATTR-CM, with a 36% reduction in All-Cause Mortality (ACM) at Month 36 and 46% reduction in composite ACM and recurrent cardiovascular-related hospitalizations (CVH) at Month 36 [1][2][5] Group 1: Clinical Study Results - The ATTRibute-CM study demonstrated the earliest known time to separation in cardiovascular outcomes at 3 months, with a 36% risk reduction in ACM at Month 36 [1][2] - Continuous treatment with acoramidis resulted in a statistically significant 34% reduction in ACM by Month 42 and a 50% reduction in cumulative frequency of CVH at Month 30 [2][4] - Evidence suggests early intervention with acoramidis leads to sustained benefits, with significant reductions in composite ACM and CVH of 46% at Month 36 and 48% at Month 42 [1][2] Group 2: Regulatory and Market Developments - A New Drug Application for acoramidis is under review by the FDA, with a PDUFA action date set for November 29, 2024 [1][5] - BridgeBio has also submitted a Marketing Authorization Application to the European Medicines Agency, with a decision expected in 2025 [5] - The company has granted exclusive rights to Bayer for the commercialization of acoramidis in Europe [5] Group 3: Company Overview - BridgeBio Pharma focuses on developing transformative medicines for genetic diseases, with a commitment to applying advances in genetic medicine [6] - The company was founded in 2015 and aims to deliver innovative treatments as quickly as possible [6]