By FieldPulse Staff · March 21, 2026
Tags: fda-approval, obesity, rare-disease, pediatric
Rhythm Pharmaceuticals received FDA approval on March 19 to expand Imcivree's label to include acquired hypothalamic obesity, a severe form of obesity caused by hypothalamic injury — typically from craniopharyngioma treatment. It is the first and only approved therapy for this condition.
Rhythm Pharmaceuticals announced on March 19, 2026 that the FDA approved a new indication for Imcivree (setmelanotide): acquired hypothalamic obesity (AHO) in adults and pediatric patients aged four and older. No therapy had previously been approved for this indication. Acquired hypothalamic obesity develops following damage or dysfunction of the hypothalamus — most commonly from craniopharyngioma tumors or their surgical treatment, radiation, or traumatic injury. The hypothalamic damage disrupts the melanocortin pathway that regulates appetite and energy expenditure, leading to severe, intrac