The COMPASS Study: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Hypertriglyceridemia

Trial Profile

The COMPASS Study: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Hypertriglyceridemia

Completed
Phase of Trial: Phase III

Latest Information Update: 10 May 2018

At a glance

  • Drugs Volanesorsen (Primary)
  • Indications Hypertriglyceridaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms COMPASS
  • Sponsors Ionis Pharmaceuticals
  • Most Recent Events

    • 10 May 2018 According to an Akcea Therapeutics media release, the U.S. Food and Drug Administration (FDA) Division of Metabolism and Endocrinology Products Advisory Committee voted 12-8 to support approval of WAYLIVRATM (volanesorsen) for the treatment of people with familial chylomicronemia syndrome (FCS).
    • 26 Apr 2018 According to an Akcea Therapeutics media release, data form this study will be presented at the National Lipid Association (NLA) Scientific Sessions 2018.
    • 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.
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