BridgeBio eyes US filing for ATTR-CM drug after new PhIII data show ‘fastest’ clinical benefit to date
BridgeBio is preparing to submit an FDA filing for its transthyretin amyloid cardiomyopathy (ATTR-CM) drug candidate, dubbed acoramidis, before the end of the year after updated registrational data indicated the treatment reduced time to clinical benefit threefold.
The Phase III ATTRibute-CM trial studied acoramidis versus placebo in 632 people with symptomatic ATTR-CM. Topline data published in July showed the drug, at 30 months, met the trial’s composite primary endpoint, which measured all-cause mortality and cardiovascular-related hospitalization rates as well as changes from baseline in NT-proBNP levels and the six-minute walk test (p<0.0001).
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.