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- BridgeBio Pharma (NASDAQ:BBIO) announced Monday that the U.S. FDA accepted its New Drug Application (NDA) for its lead asset acoramidis targeted at transthyretin amyloid cardiomyopathy (ATTR-CM), a potentially fatal heart disease.
- The agency has set November 29, 2024, as the target action date for its decision and currently doesn’t intend to hold an advisory committee meeting as part of its review.
- The NDA is based on data from the company’s ATTRibute-CM trial, which indicated a statistically significant improvement in the primary endpoint that comprised multiple measures, including mortality and hospitalization rates.
- The EU drug regulator the European Medicines Agency (EMA) has already accepted the company’s marketing authorization application for acoramidis.
- A potential approval for acoramidis will pit BBIO against Pfizer (PFE), which already markets an amyloidosis therapy called Tafamidis.