The ATTRibute-CM Phase III trial, which formed the basis for the FDA’s approval, enrolled 632 subjects with symptomatic ATTR-CM. Credit: Theerani lerdsri/Shutterstock.

The US Food and Drug Administration (FDA) has approved BridgeBio Pharma’s Attruby (acoramidis), an oral transthyretin (TTR) stabiliser, to treat adults with transthyretin amyloid cardiomyopathy (ATTR-CM).

The approval aims to decrease cardiovascular deaths and related hospitalisations.

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Attruby is the first approved product with a label that specifies near-complete TTR stabilisation.

The approval triggers a $500m payment to BridgeBio under a royalty funding agreement.

The ATTRibute-CM Phase III trial, which formed the basis for the FDA’s approval, enrolled 632 subjects with symptomatic ATTR-CM.

Participants were randomised in a 2:1 ratio to receive either Attruby or a placebo for 30 months.

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The primary endpoint of the ATTRibute-CM trial included a composite of all-cause mortality, cardiovascular-related hospitalisations, levels of N-terminal prohormone of brain natriuretic peptide and the six-minute walk test.

The trial met its primary endpoint with a win ratio of 1.8.

Attruby’s positive impact was further evidenced by its statistically significant treatment effect observed in the six-minute walk test and the Kansas City Cardiomyopathy Questionnaire.

The treatment also halved the increase in NT-proBNP levels compared to the placebo group.

In recognition of the trial participants’ contribution in the US, the company is set to provide these patients with Attruby free for life as a gesture of gratitude.

BridgeBio Pharma CEO and founder Neil Kumar stated: “With the landmark approval of Attruby, we gain the ability to serve patients with ATTR-CM. I’m grateful to each trial participant, their families and the physicians, scientists and our team at BridgeBio who made this possible.

“Our journey is not over as we look to pursue approvals globally, next in Europe, Japan and Brazil, and to continue exploring the full potential of this treatment. I am thrilled to extend our mission of putting patients first with this third FDA approval in less than 10 years.”

The company has also submitted a marketing authorisation application (MAA) to the European Medicines Agency, expecting a decision by 2025.

Bayer has secured exclusive rights from the company to commercialise acoramidis to treat ATTR-CM in Europe.

The outcomes from the Phase III ATTRibute-CM trial were published by the company in January 2024.