FDA accepts filing of NDA for acoramidis for the treatment of ATTR-CM
BridgeBio Pharma, Inc. announced that the FDA has accepted for filing the Company’s New Drug Application (NDA) for acoramidis, an investigational drug for the treatment of ATTR-CM
The application was based on positive results from ATTRibute-CM, the Company’s Phase III study designed to evaluate the efficacy and safety of acoramidis, an investigational, next-generation, orally-administered, highly potent, small molecule stabilizer of transthyretin (TTR). The FDA has set an action date of November 29, 2024 under the PDUFA. The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss the application.
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