Alnylam Pharmaceuticals (ALNY) said late Thursday that the US Food and Drug Administration has approved the supplemental new drug application for its drug Amvuttra for the treatment of cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults.
The approval of the drug, also known as vutrisiran, is meant to reduce cardiovascular mortality, cardiovascular hospitalizations, and urgent heart failure visits, the company said.
ATTR-CM is a rapidly progressive and ultimately heart disease without a cure.
The approval is based on a phase 3 clinical trial in which Amvuttra showed statistically significant improvement compared with a placebo in all of its 10 pre-specified primary and secondary endpoints, reducing mortality by 36% over 42 months, the company said.
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