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: 23 Feb 2018

At a glance

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

    • 15 Feb 2018 According to an Akcea Therapeutics media release, the Division of Metabolism and Endocrinology Products of the U.S. FDA will hold an advisory committee meeting to review data supporting the new drug application (NDA) for volanesorsen on May 10, 2018. The FDA set a PDUFA (Prescription Drug User Fee Act) goal date of August 30, 2018 for the completion of its review.
    • 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.
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