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, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
