BridgeBio Pharma (BBIO) said Friday that the US Food and Drug Administration has approved Attruby, a transthyretin stabilizer for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis in adults to reduce cardiovascular death and cardiovascular-related hospitalization.
The approval is based on results of the ATTRibute-CM phase 3 study, which met its primary endpoint by demonstrating a statistically significant treatment effect of Attruby versus placebo at 30 months.
With this approval, BridgeBio said it will receive a $500 million payment under its royalty funding agreement.
The company also said it submitted a marketing authorization application to the European Medicines Agency, with a decision expected in 2025. It has granted exclusive rights to Bayer to commercialize the drug in Europe.
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