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A Phase 3 Multi-Center, One-Year, Open-Label Study of Setmelanotide in Pediatric Patients Aged 2 to <6 Years of Age With Rare Genetic Causes of Obesity

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Trial Profile

A Phase 3 Multi-Center, One-Year, Open-Label Study of Setmelanotide in Pediatric Patients Aged 2 to <6 Years of Age With Rare Genetic Causes of Obesity

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Aug 2024

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At a glance

  • Drugs Setmelanotide (Primary)
  • Indications Bardet-Biedl Syndrome; Obesity
  • Focus Registrational; Therapeutic Use
  • Acronyms VENTURE
  • Sponsors Rhythm

    • Most Recent Events

    • 26 Aug 2024 According to a Rhythm media release, company announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for IMCIVREE (setmelanotide) based on the data from this study. The FDA has granted Priority Review of the sNDA and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2024.
    • 31 Jul 2024 According to a Rhythm media release, company announced that the European Commission (EC) expanded the marketing authorization for IMCIVREE (setmelanotide) to include children between 2 and younger than 6 years old with obesity due to Bardet Biedl syndrome (BBS) or pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency.
    • 28 Jun 2024 According to a Rhythm Pharmaceuticals media release, the European Medicines Agency's (EMA) CHMP has adopted a positive opinion recommending the marketing authorization for IMCIVREE (setmelanotide) include children between 2 and younger than 6 years old with obesity due to Bardet Biedl syndrome (BBS) or pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. EC decision anticipated in second half.

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