Alnylam's Amvuttra Gets Approval for Expanded Indication From FDA

Dow Jones
21 Mar
 

By Josh Beckerman

 

Alnylam Pharmaceuticals' amyloidosis drug Amvuttra received Food and Drug Administration approval for an expanded indication.

The drug was approved for treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart-failure visits.

Cantor Fitzgerald wrote that "The most important thing is that it's approved with a broad label: by this, we mean mortality language is in fact included on the front page" and that the language about urgent heart failure visits is a differentiator compared with other products.

Amvuttra was previously approved for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

 

Write to Josh Beckerman at josh.beckerman@wsj.com

 

(END) Dow Jones Newswires

March 20, 2025 18:47 ET (22:47 GMT)

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