Alnylam Pharmaceuticals Announces FDA Approval of AMVUTTRA for ATTR-CM

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announced that the FDA approved its supplemental New Drug Application for AMVUTTRA (vutrisiran) for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults. This approval expands the indication for AMVUTTRA, making it the first and only therapeutic approved by the FDA for both ATTR-CM and polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults. The decision is based on positive results from the HELIOS-B Phase 3 clinical trial, which demonstrated significant improvements in cardiovascular outcomes, functional capacity, and quality of life.

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About Alnylam Pharmaceuticals Inc.

Alnylam Pharmaceuticals Inc. is a pioneering biotechnology company dedicated to transforming the lives of patients through RNA interference (RNAi) therapeutics. This scientific approach allows for innovative treatments that can silence genes responsible for certain diseases, offering a unique angle on genetic therapies. Alnylam's primary focus is on developing therapeutics for genetic, cardio-metabolic, hepatic infectious, and central nervous system diseases, contributing to redefining how these conditions are treated. The company's groundbreaking work in RNAi provides a platform for addressing otherwise untreatable or poorly managed medical conditions, positioning it as a leader in the biotechnology sector. With numerous collaborations, partnerships, and a growing pipeline of therapeutics, Alnylam plays a crucial role in advancing modern medicine and contributing to the evolving landscape of genetic therapeutics. Headquartered in Cambridge, Massachusetts, Alnylam underscores the critical intersection of innovation, medicine, and gene science in the financial and pharmaceutical markets.