A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients With Familial Amyloid Polyneuropathy

Trial Profile

A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients With Familial Amyloid Polyneuropathy

Completed
Phase of Trial: Phase II/III

Latest Information Update: 08 Jan 2018

At a glance

  • Drugs Inotersen (Primary)
  • Indications Amyloid polyneuropathy
  • Focus Registrational; Therapeutic Use
  • Acronyms NEURO-TTR
  • Sponsors Ionis Pharmaceuticals
  • Most Recent Events

    • 08 Jan 2018 Results presented in an Ionis Pharmaceuticals Media Release.
    • 08 Jan 2018 According to an Ionis Pharmaceuticals media release, New Drug Application (NDA) for inotersen has been accepted for Priority Review by the U.S. Food and Drug Administration (FDA). The FDA has set a Prescription Drug User Fee Act (PDUFA) date of July 6, 2018.
    • 06 Nov 2017 According to an Ionis Pharmaceuticals media release, the company has submitted an NDA to the US FDA for inotersen based on the results of this trial.
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