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Vutrisiran - Alnylam Pharmaceuticals

Drug Profile

Vutrisiran - Alnylam Pharmaceuticals

Alternative Names: ALN-65492; ALN-TTRsc02; AMVUTTRA

Latest Information Update: 16 Jun 2025

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At a glance

  • Originator Alnylam Pharmaceuticals
  • Class Amides; Amino sugars; Drug conjugates; Pyrrolidines; Small interfering RNA
  • Mechanism of Action Prealbumin expression inhibitors; RNA interference
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Transthyretin-related hereditary amyloidosis
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Transthyretin-related hereditary amyloidosis

Most Recent Events

  • 09 Jun 2025 European Commission approves Vutrisiran (AMVUTTRA®) for treatment of Transthyretin-related hereditary amyloidosis with cardiomyopathy (ATTR-CM) in European Union, Iceland, Liechtenstein, and Norway
  • 31 May 2025 European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) adopts a positive opinion on the maintenance of the EU Orphan Designation for Vutrisiran (AMVUTTRA®) in ATTR amyloidosis
  • 17 May 2025 Alnylam Pharmaceuticals expects a formal regulatory decision by the European Commission of the EMA by the third quarter of 2025 for the use of vutrisiran for the treatment of cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults

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