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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: 13 Nov 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 - Hyperlipoproteinaemia; Lipodystrophy
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 05 Nov 2018 Akcea Therapeutics receives a preliminary notification of a Notice of Non-compliance withdrawal letter from Health Canada for Hyperlipoproteinaemia type I prior to November 2018
  • 27 Aug 2018 Ionis pharmaceuticals receives complete response letter from US FDA for Hyperlipoproteinaemia type I
  • 02 Aug 2018 Volanesorsen licensed to PTC Therapeutics in Latin America
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