FDA approves setmelanotide (Imcivree) for acquired hypothalamic obesity

The FDA expanded the label of Rhythm Pharmaceuticals' setmelanotide (Imcivree), an MC4R agonist, to treat acquired hypothalamic obesity in adults and children aged 4 and older, the first approved therapy for the condition. Acquired hypothalamic obesity usually follows damage to the hypothalamus from tumors such as craniopharyngioma or their treatment. In the phase 3 TRANSCEND trial of 142 patients, BMI fell 15.8% on setmelanotide versus a 2.6% rise on placebo at 52 weeks, an 18.4% placebo-adjusted difference.