Alnylam Pharmaceuticals Recieives US FDA Approval for ATTR-CM Drug

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Alnylam Pharmaceuticals Recieives US FDA Approval for ATTR-CM Drug

, MT Newswires - 3:58 AM ET 3/21/2025 default

03:58 AM EDT, 03/21/2025 (MT Newswires) -- 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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