Erica Friedman • June 17, 2025
Alnylam Announces FDA Approval of AMVUTTRA® (vutrisiran) for Adults with ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)

AMVUTTRA® (vutrisiran) has been approved by the U.S. Food and Drug Administration (FDA) to treat ATTR-CM in adults. 

AMVUTTRA is an RNAi therapeutic that works upstream to deliver rapid knockdown of TTR, addressing the disease at its source, with only four convenient subcutaneous doses per year. By rapidly knocking down TTR production, AMVUTTRA substantially decreases deposition of TTR fibrils, which form amyloid and cause irreversible cardiovascular damage and premature death in patients with ATTR-CM.


Alnylam is incredibly grateful to the patients who participated in clinical trials to advance the treatment of ATTR-CM, including those who participated in the HELIOS-B study. We’re also thankful to their families who supported them and the incredible efforts of the advocacy community, investigators and study staff for their important contributions.

 

To ensure patients who need AMVUTTRA have access to it, Alnylam offers multiple patient support services and resources through Alnylam Assist®, designed to help patients and their families navigate the treatment journey. As part of Alnylam Assist®, Alnylam offers low or no cost programs for eligible patients and most patients treated with AMVUTTRA pay $0 out of pocket. If you would like to learn more about how Alnylam can support patients, you can visit AlnylamAssist.com/AMVUTTRA.


For more information, please see the full Anylam press release.


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