BridgeBio Pharma Presented Initial Outcomes From The ATTRibute-CM Open-label Extension Study Of Acoramidis In ATTR-CM At The AHA Scientific Sessions; Acoramidis Demonstrated The Earliest Known Time To Separation In Cardiovascular Outcomes In The ATTRibute-CM Study (3 Months), With Statistically Significant Risk Reduction Of 36% On All-Cause Mortality Alone At Month 36 Within The Open Label Extension
- Acoramidis demonstrated the earliest known time to separation in cardiovascular outcomes in the ATTRibute-CM study (3 months), with statistically significant risk reduction of 36% on All-Cause Mortality (ACM) alone at Month 36 within the Open Label Extension
- The continued curve separation of the composite endpoint of ACM and recurrent cardiovascular-related hospitalizations (CVH) emphasizes the importance of early intervention resulting in early and sustained clinical benefits, with acoramidis demonstrating 46% (p<0.0001) and 48% (p<0.0001) reductions in the composite endpoint of ACM and recurrent CVH at Months 36 and 42, respectively
- The preliminary results from this ongoing OLE study were also simultaneously published in Circulation
- A New Drug Application for acoramidis for the treatment of ATTR-CM is currently under review with the FDA, with a PDUFA action date of November 29, 2024
PALO ALTO, Calif., Nov. 18, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a new type of biopharmaceutical company focused on genetic diseases, presented positive initial outcomes from the ATTRibute-CM open-label extension (OLE) study of acoramidis in ATTR-CM at the American Heart Association (AHA) Scientific Sessions. ATTRibute-CM was designed to evaluate the efficacy and safety of acoramidis, an investigational, near-complete, orally-administered, small molecule stabilizer of TTR. The preliminary results from this ongoing OLE study were also simultaneously published in Circulation. The OLE study involves 330 participants who completed the 30-month ATTRibute-CM Phase 3 study.
