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.
免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。