Alnylam Pharmaceuticals ALNY announced that the FDA had approved its regulatory filing seeking the label expansion of its lead drug, Amvuttra (vutrisiran), for treating the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality,

U.S. Food and Drug Administration approved Alnylam's drug to treat a rare and deadly heart disease on Thursday, allowing the entry of a new type of medicine in a market dominated by Pfizer's blockbuster Vyndaqel.

The approval expands the indication for Amvuttra, which now becomes the first and only therapeutic approved by the FDA for ATTR-CM and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.