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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