BridgeBio Pharma’s Attruby (Acoramidis) Secures the US FDA’s Approval to Treat ATTR-CM 

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• The US FDA has approved Attruby (oral stabilizer of Transthyretin) to reduce cardiovascular death & associated hospitalization in ATTR-CM patients. The MAA is also under review in the EU, with decision anticipated in 2025 

• Approval was based on P-III (ATTRibute-CM) study of Attruby vs PBO in ATTR-CM patients (n=632). It achieved its 1EP, showing a 42% reduced ACM & recurrent CVH events, 50% reduced cumulative frequency of CVH events at 30mos. & a Win Ratio of 1.8 for a composite of ACM, CVH, NT-proBNP & 6-minute walk distance 

• Bayer holds exclusive commercial rights of Attruby in the EU & will get $500M under their royalty agreement 

Ref: GlobeNewswire | Image: BridgeBio Pharma| Press Release

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