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

 
• By Alaric DeArment

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...

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