Alnylam's Amvuttra Gets Approval for Expanded Indication From FDA

Dow Jones
03-21
 

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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