Attruby™ (acoramidis), a Near Complete TTR Stabilizer (≥90%), approved by FDA to Reduce Cardiovascular Death and Cardiovascular-related Hospitalization in ATTR-CM Patients

Core Insights - BridgeBio Pharma has received FDA approval for Attruby™, the first and only product with a label indicating near-complete stabilization of Transthyretin (TTR) for treating adults with ATTR-CM, aimed at reducing cardiovascular death and related hospitalizations [1][9] Group 1: Product Efficacy and Study Results - Attruby demonstrated a 42% reduction in composite all-cause mortality (ACM) and recurrent cardiovascular-related hospitalizations (CVH) at Month 30 compared to placebo [1] - The treatment showed a 50% reduction in cumulative frequency of CVH events at Month 30 relative to placebo [1] - In the ATTRibute-CM Phase 3 study, Attruby met its primary endpoint with a Win Ratio of 1.8 (p<0.0001) and showed significant improvements in quality of life metrics [4] Group 2: Patient Support and Access Programs - BridgeBio will provide Attruby free for life to U.S. clinical trial participants as a gesture of appreciation [1] - The company offers a patient support services program, ForgingBridges™, to assist patients and families in accessing Attruby, including insurance resources and financial assistance [5] Group 3: Financial and Market Implications - Following the approval, BridgeBio will receive a $500 million payment under its royalty funding agreement [1] - The company plans to pursue global approvals for Attruby, with a Marketing Authorization Application submitted to the European Medicines Agency, expecting a decision in 2025 [7]