BridgeBio Pharma (BBIO) said Thursday that the Japanese Ministry of Health, Labor and Welfare has approved acoramidis, under the brand name Beyonttra, to treat adults with transthyretin-mediated amyloid cardiomyopathy, a heart condition caused by abnormal deposits of the transthyretin protein in the heart muscle.
The biopharmaceutical company said the approval is based on results from a phase 3 study conducted in Japan in which acoramidis was generally well tolerated and had a 0% mortality rate during a 30-month treatment period.
Shares were 0.9% higher in recent premarket activity.
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