BridgeBio: NDA OKd for Acoramidis for Treatment of Transthyretin Amyloid Cardiomyopathy

 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 for a large proportion of patients on laboratory and functional measures

- ATTRibute-CM results also demonstrated rapid clinical benefit on the composite endpoint of all-cause mortality (ACM) and CVH in patients treated with acoramidis, with time-to-first event Kaplan-Meier curves separating at month 3 and continuing to diverge steadily through Month 30

https://www.globenewswire.com/news-release/2024/02/05/2823433/0/en/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-Cardi.html