Metreleptin - Novelion Therapeutics

Drug Profile

Metreleptin - Novelion Therapeutics

Alternative Names: Human recombinant methionyl leptin; Methionyl human leptin; Myalept; r-metHuLeptin; Recombinant methionyl human leptin

Latest Information Update: 24 Mar 2018

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At a glance

  • Originator Amgen
  • Developer Amgen; Beth Israel Deaconess Medical Center; Novelion Therapeutics; Shionogi; University of Texas Southwestern Medical Center
  • Class Adipokines; Antihyperglycaemics; Antihyperlipidaemics; Obesity therapies
  • Mechanism of Action Glucose modulators; Hormone modulators; Lipid modulators
  • Orphan Drug Status

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

    Yes - Lipodystrophy
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Lipodystrophy
  • Phase II Amenorrhoea
  • Phase I Type 1 diabetes mellitus

Most Recent Events

  • 12 Jun 2017 Efficacy and adverse events data from a post-hoc analysis of phase II trial in Lipodystrophy presented at the 77th Annual Scientific Sessions of the American Diabetes Association (ADA-2017)
  • 15 Mar 2017 Novelion announces intention to submit sBLA to US FDA for a subset of partial lipodystrophy patients in 1H 2017
  • 23 Jan 2017 European Medicines Agency accepts MAA for metreleptin for Lipodystrophy for review
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