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Alnylam Pharmaceuticals’ Amvuttra Receives the EC’s Approval for ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)

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  • The EC has approved Amvuttra (vutrisiran) to treat ATTR-CM adults  as an additional indication, based on the global P-III (HELIOS-B) study assessing it vs PBO in ATTR-CM pts
  • The study met all ten 1 & 2EPs across both overall & monotx. arms, showing improved outcomes of mortality, CV events & functional capacity with 6min. walk test
  • The trial also showed benefits across health status, QoL (Kansas City Cardiomyopathy Questionnaire), plus heart failure symptoms & severity (NYHA class). In the overall population, the primary composite endpoint was reduced by 28%, and mortality was reduced by 36% over 42mos. Data was published in The NEJM

Ref: Businesswire | Image: Alnylam Pharmaceuticals| Press Release

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