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.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.