BridgeBio Pharma : FDA Approves Heart Disease Drug 'acoramidis'

(RTTNews) - 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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