
BridgeBio Receives the MHLW’s Approval for Beyonttra (Acoramidis) for Transthyretin-Mediated Amyloidosis Cardiomyopathy (ATTR-CM)
Shots:
- Japan’s MHLW has approved Beyonttra to treat ATTR-CM in adult pts based on P-III (ATTRibute-CM) study assessing Beyonttra (BID, oral) vs PBO (n=632) in ATTR-CM pts; commercialization to begin in H1’25
- Trial showed 42% decrease in composite ACM & recurrent CVH events, plus 50% reduction in cumulative frequency of CVH events at 30mos., with pts depicting favorable safety in Japanese trial; Trial showed early, sustained separation in ACM/CVH at 3mos. vs PBO
- As per the 2019 agreement, BridgeBio will receive $30M milestone payment from Alexion (AstraZeneca) upon Japanese approval, along with low double digits tiered royalties on net sales
Ref: BridgeBio | Image: BridgeBio
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