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An early access program for patients with hypothalamic obesity in France to receive setmelanotide treatment

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Trial Profile

An early access program for patients with hypothalamic obesity in France to receive setmelanotide treatment

Status: Completed
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 25 Nov 2024

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At a glance

  • Drugs Setmelanotide (Primary)
  • Indications Hypothalamic disorders; Obesity
  • Focus Therapeutic Use
  • Sponsors Rhythm

    • Most Recent Events

    • 18 Nov 2024 According to a Rhythm Pharmaceuticals media release, the company announced the presentation of new, real-world data that showed 4 pediatric patients with acquired hypothalamic obesity or congenital hypothalamic obesity achieved >5% weight reduction at three months on setmelanotide, at a poster-presentation during the 62nd annual meeting of the European Society for Paediatric Endocrinology (EPSE), held 16-18 Nov, 2024 in Liverpool, England.
    • 11 Aug 2023 New trial record
    • 07 Aug 2023 According to a Rhythm Pharmaceuticals media release, company announced that the French National Agency for Medicines and Health Products Safety (ANSM) and French National Authority for Health (HAS) have granted pre-marketing early access authorization AP1 (Autorisation d'Acces Precoce), for IMCIVREE (setmelanotide) for patients with lesional hypothalamic obesity.

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