BridgeBio’s Beyonttra (Acoramidis) Gets the EU approval to Treat Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
Shots:
- The EU granted marketing authorization to Beyonttra (acoramidis) to treat wild-type or variant ATTR-CM in adult pts.; launch expected in 1H’25
- The approval was supported by the results of P-III (ATTRibute-CM) study of Beyonttra (BID, oral) vs PBO (n=632) in ATTR-CM pts.. It achieved its 1EP, showing a 42% reduced composite ACM & recurrent CVH events & 50% reduced cumulative frequency of CVH events at 30mos.
- As per the March'24 agreement, BridgeBio will receive $75M milestone payment from Bayer upon EU approval, along with tiered royalties starting in the low thirties percent on acoramidis sales in the EU; approval is under review by the PMDA and ANVISA
Ref: BridgeBio | Image: BridgeBio
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