Alnylam Pharmaceuticals Inc. has announced that the European Commission $(EC)$ has granted approval for AMVUTTRA® (vutrisiran) for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). This makes AMVUTTRA the first and only RNA interference (RNAi) therapeutic approved by the EC for both cardiomyopathy and polyneuropathy manifestations of hereditary transthyretin-mediated amyloidosis (hATTR) in adults. The approval, based on the HELIOS-B Phase 3 Study, demonstrates a significant reduction in all-cause mortality and the preservation of functional capacity and quality of life. This decision follows recent authorizations in the U.S. and Brazil and marks a significant step toward addressing the needs of approximately 100,000 people affected by ATTR amyloidosis across Europe.
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