- - In this exploratory substudy, treatment with acoramidis was associated with possible cardiac structural and functional improvement compared with placebo, with potential cardiac amyloid regression
- - The data demonstrate that targeting near-complete transthyretin (TTR) stabilization with acoramidis may enable cardiac remodeling and functional recovery in patients with ATTR-CM
- - These results are the first prospective, longitudinal evaluation of cardiac structure and function by CMR imaging in a double-blind, placebo-controlled, interventional study in ATTR-CM
- - The findings from this study build upon positive results from BridgeBio's global ATTRibute-CM Phase 3 trial, wherein the primary endpoint was met (Win Ratio of 1.8) with a high statistical significance (p<0.0001); the substudy data are consistent with the cardiovascular clinical benefits observed with acoramidis
- - Acoramidis was well-tolerated, with no safety signals of potential clinical concern observed
- - BridgeBio's New Drug Application (NDA) has been accepted by the U.S. Food and Drug Administration (FDA) with a PDUFA action date of November 29, 2024; a Marketing Authorization Application (MAA) for acoramidis has been accepted by the European Medicines Agency (EMA), with an expected decision in 2025
Reported Sunday, BridgeBio Pharma Presented Results From The Exploratory Cardiac Magnetic Resonance Imaging Substudy Of ATTRibute-CM, Its Phase 3 Trial Of Acoramidis In ATTR-CM
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