A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)

Completed
Phase of Trial: Phase III

Latest Information Update: 15 Nov 2017

At a glance

  • Drugs Volanesorsen (Primary)
  • Indications Hyperlipoproteinaemia type I
  • Focus Registrational; Therapeutic Use
  • Acronyms APPROACH
  • Sponsors Ionis Pharmaceuticals
  • Most Recent Events

    • 15 Nov 2017 According to an Akcea Therapeutics media release, all of its marketing applications for volanesorsen have been accepted for review in the U.S., EU and Canada for the treatment of patients with familial chylomicronemia syndrome (FCS).
    • 06 Nov 2017 According to an Akcea Therapeutics media release, data from this will be presented at a number of medical conferences including an oral presentation at the American Pancreatic Association 2017.
    • 12 Sep 2017 According to an Akcea Therapeutics media release, based on the data from the Phase 3 APPROACH and COMPASS studies, the company has filed a New Drug Submission (NDS) to Health Canada for volanesorsen for the treatment of familial chylomicronemia syndrome (FCS) and received a priority review for the volanesorsen NDS from Health Canada.
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