BridgeBio Pharma Announces U.S. Food and Drug Administration (FDA) Acceptance of New Drug Application (NDA) for Acoramidis for the Treatment of Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
BridgeBio(BBIO) Newsfilter·2024-02-05 20:30- Accepted with Prescription Drug User Fee Act (PDUFA) action date of November 29, 2024; FDA not currently planning to hold an advisory committee meeting to discuss application - Marketing Authorization Application accepted by the European Medicines Agency (EMA) with additional global regulatory submissions planned - In ATTRibute-CM, acoramidis treatment demonstrated an 81% absolute survival rate and a 0.29 observed mean annual cardiovascular-related hospitalization (CVH) frequency, as well as improvements ...