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An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients With Familial Amyloid Polyneuropathy (FAP)

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Trial Profile

An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients With Familial Amyloid Polyneuropathy (FAP)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Feb 2023

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At a glance

  • Drugs Inotersen (Primary)
  • Indications Amyloid polyneuropathy; Familial amyloid neuropathy
  • Focus Adverse reactions; Pharmacodynamics; Registrational; Therapeutic Use
  • Acronyms NEURO-TTR OLE
  • Sponsors Ionis Pharmaceuticals

Most Recent Events

  • 14 Nov 2022 Results assessing longer-term efficacy and safety data for inotersen, with a median treatment exposure of 3 years,published in the Journal of Neurology.
  • 01 Oct 2022 Results of an analysis assessing the long-term treatment effects of inotersen on health-related quality of life in patients with hATTR amyloidosis with polyneuropathy published in the Muscle and Nerve
  • 22 Jun 2021 Results assessing efficacy and safety with greater than 3 years of inotersen treatment for the polyneuropathy of hereditary transthyretin amyloidosis, presented at the 7th Congress of the European Academy of Neurology

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