BridgeBio Pharma : FDA Approves Heart Disease Drug 'acoramidis'
BridgeBio Pharma Inc. announced that the FDA has approved Attruby (acoramidis) for treating adults with Transthyretin amyloid cardiomyopathy (ATTR-CM). This drug aims to reduce cardiovascular death and related hospitalizations. The approval follows positive results from the ATTRibute-CM Phase 3 study. BridgeBio will receive a payment under a royalty funding agreement and has submitted a Marketing Authorization Application to the European Medicines Agency, with a decision expected in 2025. Bayer has exclusive rights to commercialize acoramidis in Europe.
BridgeBio Pharma Inc. (BBIO) announced that the U.S. Food and Drug Administration approved Attruby or acoramidis, an orally-administered near-complete stabilizer of Transthyretin for the treatment of adults with Transthyretin amyloid cardiomyopathy (ATTR-CM) to reduce cardiovascular death and cardiovascular-related hospitalization.
The FDA approval is based on positive results seen in the ATTRibute-CM Phase 3 study, where Attruby significantly reduced death and cardiovascular-related hospitalization, and improved quality of life.
With this approval, BridgeBio will receive a $500 million payment under our royalty funding agreement.
BridgeBio submitted a Marketing Authorization Application to the European Medicines Agency, with a decision expected in 2025. BridgeBio has granted exclusive rights to Bayer to commercialize acoramidis for ATTR-CM in Europe.
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