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
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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
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Bayer holds exclusive commercial rights of Attruby in the EU & will get $500M under their royalty agreement
Ref: BridgeBio | Image: BridgeBio
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies. He can be contacted at connect@pharmashots.com
