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An Open-Label Study of Volanesorsen Administered Subcutaneously to Patients with Familial Chylomicronemia Syndrome (FCS)

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Trial Profile

An Open-Label Study of Volanesorsen Administered Subcutaneously to Patients with Familial Chylomicronemia Syndrome (FCS)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Aug 2021

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At a glance

  • Drugs Volanesorsen (Primary)
  • Indications Hyperlipoproteinaemia type I
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms APPROACH Open Label Extension
  • Sponsors Akcea Therapeutics; Ionis Pharmaceuticals

Most Recent Events

  • 23 Aug 2021 According to a PTC Therapeutics media release, Brazilian Health Regulatory Agency, ANVISA (Agencia Nacional de Vigilancia Sanitaria), has approved Waylivra (volanesorsen) as the first treatment for familial chylomicronemia syndrome (FCS) in Brazil.This approval is based on results from the Phase 3 APPROACH study and the APPROACH Open Label Extension study and is supported by results from the Phase 3 COMPASS study.
  • 02 Oct 2020 Status changed from active, no longer recruiting to completed.
  • 02 Oct 2020 Planned primary completion date changed from 1 Jun 2020 to 1 Oct 2020.

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