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A single-arm, open-label safety study of MYALEPT in patients with generalized lipodystrophy

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Trial Profile

A single-arm, open-label safety study of MYALEPT in patients with generalized lipodystrophy

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 08 Feb 2024

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At a glance

  • Drugs Metreleptin (Primary)
  • Indications Congenital generalised lipodystrophy
  • Focus Adverse reactions; Registrational

    • Most Recent Events

    • 05 Feb 2024 According to a Chiesi media release, the Health Canada granted approval to MYALEPTA (metreleptin for injection), for the treatment of patients with lipodystrophy.
    • 07 Aug 2018 New trial record
    • 31 Jul 2018 The EC has granted marketing authorization for MYALEPTA, as an adjunct to diet, as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy patients with confirmed congenital generalized LD or acquired generalized LD in adults and children 2 years of age and above; or with confirmed familial partial LD or acquired partial LD, in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control.

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