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: 08 Aug 2017

At a glance

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

    • 08 Aug 2017 According to an Akcea Therapeutics media release, the company is on track to file for regulatory approval in the U.S. and Canada in September 2017.
    • 27 Jul 2017 According to an Akcea Therapeutics media release, the company has submitted an MAA to the European Medicines Agency (EMA) for volanesorsen for the treatment of patients with familial chylomicronemia syndrome (FCS). The submission was based on data from the Phase 3 APPROACH and COMPASS studies.
    • 06 Mar 2017 According to an Akcea Therapeutics, Ionis Pharmaceuticals media release, additional data from the study will be presented at an upcoming medical meeting.
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