Alnylam's Amvuttra wins key approval in ATTR-CM, teeing up showdown with Pfizer

Despite growing competition in the transthyretin amyloid cardiomyopathy (ATTR-CM) field, Alnylam is hoping its RNA interference approach can set it apart from its peers. And now, the Massachusetts-based drugmaker has a fresh FDA approval to support its thesis.

The FDA has signed off on Alnylam’s Amvuttra, also known as vutrisiran, as a treatment for cardiomyopathy of wild-type or hereditary ATTR-CM in adults to reduce the chance of cardiovascular death, hospitalizations and urgent heart failure visits.

Thanks to a previous nod in 2022, Amvuttra is now the first medication approved in the U.S. to treat both ATTR-CM and polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN), Alnylam noted in a Thursday release.