Rhythm Pharmaceuticals announced that the European Commission has granted marketing authorization for Imcivree (setmelanotide) for the treatment of obesity and control of hunger in patients with acquired hypothalamic obesity, making it the first therapy to hold both US FDA approval and EC authorization for this rare neuroendocrine condition.

The EC authorization covers adults and children aged 4 years and above with acquired hypothalamic obesity due to hypothalamic injury or impairment. The approval expands the existing European label for setmelanotide, which had previously been authorized in the EU for obesity associated with Bardet-Biedl syndrome and certain genetic deficiencies including POMC, PCSK1, and LEPR. Rhythm estimates approximately 10,000 people are living with acquired hypothalamic obesity in Europe. The company said commercial launches are anticipated in 2027, pending country-by-country access negotiations with local health authorities.

The EC decision is based on data from the pivotal 120-patient cohort of the Phase III TRANSCEND trial, which evaluated setmelanotide in patients with acquired hypothalamic obesity. The trial met its primary endpoint, demonstrating a statistically significant placebo-adjusted reduction in body mass index of -19.8%. Participants on setmelanotide achieved a -16.5% mean BMI reduction from baseline at 52 weeks compared with a +3.3% increase in the placebo group. The most common adverse reactions reported in more than 20% of participants included nausea, vomiting, diarrhea, injection site reaction, skin hyperpigmentation, and headache.

Acquired hypothalamic obesity most frequently follows the growth or treatment of craniopharyngioma, astrocytoma, or other hypothalamic-pituitary tumors, and can also result from traumatic brain injury, stroke, or anatomic abnormalities. The condition involves disruption of MC4R pathway signaling, which regulates energy balance and body weight. Prior to setmelanotide’s approvals, no authorized treatment options existed for this population. The US FDA approved the supplemental new drug application for this indication in March 2026, and the EC authorization now extends that regulatory recognition to Europe.

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