BridgeBio Pharma Gets FDA Acceptance for NDA of Acoramidis

By Chris Wack

BridgeBio Pharma said that the U.S. Food and Drug Administration has accepted for filing the New Drug Application for acoramidis, an investigational drug for the treatment of Transthyretin Amyloid Cardiomyopathy.

The biopharmaceutical company said the application was based on positive results from a Phase 3 study designed to evaluate the efficacy and safety of acoramidis.

The FDA has set an action date of Nov. 29, 2024 under the Prescription Drug User Fee Act . The FDA also notified the company that it isn't currently planning to hold an advisory committee meeting to discuss the application.

In July 2023, BridgeBio reported positive results, saying acoramidis was well-tolerated, with no safety signals of potential clinical concern identified.

The company also received acceptance of its Marketing Authorization Application with the European Medicines Agency and is preparing for additional global regulatory submissions.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

February 05, 2024 08:12 ET (13:12 GMT)

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