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

Latest Information Update: 17 Nov 2017

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At a glance

  • Originator Isis Pharmaceuticals
  • Developer Akcea Therapeutics; Ionis Pharmaceuticals
  • Class Antihyperlipidaemics; Antisense oligonucleotides; Antisense RNA
  • 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

  • 15 Nov 2017 EMA accepts MAA for volanesorsen for Hyperlipoproteinaemia type I for review
  • 15 Nov 2017 FDA assigns PDUFA action date of 30/08/2018 for Volanesorsen for Hyperlipoproteinaemia type I
  • 15 Nov 2017 US FDA accepts NDA for volanesorsen for Hyperlipoproteinaemia type I for review
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