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
Latest Information Update: 19 Jul 2024
At a glance
- Drugs Setmelanotide (Primary)
- Indications Bardet-Biedl Syndrome; Obesity
- Focus Registrational; Therapeutic Use
- Acronyms VENTURE
- Sponsors Rhythm
- 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.
- 12 May 2024 This trial has been Discontinued in Spain, according to European Clinical Trials Database record.
- 07 May 2024 According to a Rhythm Pharmaceuticals media release, company expect to complete submission of a supplementary New Drug Application (sNDA) to the FDA seeking a label expansion for IMCIVREE to treat pediatric patients between 2 and younger than 6 years old in approved indications in the second quarter of 2024, with EMA approval for this pediatric expansion potentially in the fourth quarter of 2024.