Volanesorsen - Ionis Pharmaceuticals

Drug Profile

Volanesorsen - Ionis Pharmaceuticals

Alternative Names: IONIS-304801; IONIS-APOCIII; IONIS-APOCIIIRx; ISIS-304801; ISIS-APOCIII; ISIS-APOCIII-Rx; Volanesorsen; Volanesorsen sodium; WAYLIVRA

Latest Information Update: 14 May 2018

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At a glance

  • Originator Isis Pharmaceuticals
  • Developer Akcea Therapeutics; Ionis Pharmaceuticals
  • Class Antihyperlipidaemics; Antisense oligonucleotides; Antisense RNA; Cardiovascular therapies
  • Mechanism of Action Apolipoprotein C-III inhibitors; RNA modulators
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Hyperlipoproteinaemias; Lipodystrophy
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Hyperlipoproteinaemia type I
  • Phase III Hypertriglyceridaemia; Lipodystrophy
  • Preclinical Cardiovascular disorders

Most Recent Events

  • 10 May 2018 Division of Metabolism and Endocrinology Products Advisory Committee of the US FDA recommends approval of Volanesorsen for Hyperlipoproteinaemia type I (familial chylomicronaemia syndrome)
  • 02 May 2018 Volanesorsen is available in a compassionate use programme for the treatment of Hyperlipoproteinaemia type I in USA
  • 21 Mar 2018 The Medicines and Healthcare Products Regulatory Agency grants early access to volanesorsen for Hyperlipoproteinaemia type I (familial chylomicronaemia syndrome) in United Kingdom
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