BridgeBio Comes Back With Positive Phase III Results For Acoramidis In ATTR-CM

The ATTRibute-CM study met its primary endpoint as well as key secondary endpoints, and the company plans to file for US FDA approval before the end of 2023.

BridgeBio announced data from its Phase III trial of acoramidis in ATTR-CM • Source: Shutterstock

BridgeBio Pharma, Inc.’s acoramidis found redemption, with the Phase III ATTRibute-CM showing positive results in transthyretin amyloid cardiomyopathy (ATTR-CM) as compared with the negative results at an interim analysis at the end of 2021. The positive Phase III data should carry the drug through to regulatory approval, but it may face commercial headwinds due to the entrenched position of Pfizer Inc.’s Vyndaqel/Vyndamax (tafamidis) franchise.

BridgeBio announced the ATTRibute-CM results on 17 July, stating that the study met its primary endpoint – consisting of a hierarchical analysis of all-cause mortality, frequency of cardiovascular-related hospitalization, change from baseline in N-terminal prohormone of brain natriuretic peptide (NT-proBNP)

More from Clinical Trials

More from R&D

Leo Roars To A Profit In Q1 As Adbry Grows In US

 
• By 

The Danish firm's atopic dermatitis drug is holding its own despite strong competition from Sanofi/Regeneron’s Dupixent.

Lundbeck Lifted By Leap In Migraine Therapy Sales

 
• By 

Vyepti revenues rise by nearly 70% in the first quarter.

‘Market Developments’ Persuade Galapagos To Rethink Spin-Off

 

CEO Paul Stoffels exits early to be succeeded by Henry Gosebruch, who will now consider ‘all options’ for the Belgian firm as it tries to claw back investor confidence.