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StocksMedium•1 May 2026•

1 min read

EC Authorizes Rhythm Pharmaceuticals' IMCIVREE for Acquired Hypothalamic Obesity

Key Facts

1The European Commission granted marketing authorization for IMCIVREE (setmelanotide) for the treatment of obesity and control of hunger in patients with acquired hypothalamic obesity.

2The therapy is the first to be both FDA-approved and EC-authorized specifically for acquired hypothalamic obesity.

Rhythm Pharmaceuticals has received marketing authorization from the European Commission for its drug IMCIVREE (setmelanotide) to treat obesity and control hunger. The authorization specifically targets patients with acquired hypothalamic obesity, covering adults and children aged 4 and older. Notably, IMCIVREE is the first therapy to be both FDA-approved and EC-authorized specifically for this rare condition. The decision follows clinical evidence supporting the drug's efficacy in treating obesity caused by hypothalamic injury or impairment. This regulatory milestone marks a significant expansion of the company's addressable market within the European Union. By addressing a previously unmet medical need, Rhythm Pharmaceuticals strengthens its commercial portfolio in the specialized biotechnology sector.