FDA expands Rhythm’s Imcivree to acquired hypothalamic obesity — First drug for the rare condition

The FDA widened the label for Rhythm Pharmaceuticals’ Imcivree (setmelanotide) to include acquired hypothalamic obesity in adults and children aged four and older. Clinical trials showed Imcivree produced roughly 18 percentage points greater weight loss versus placebo in the target population. Rhythm’s CEO David Meeker called the approval transformative and estimated the addressable market could exceed $1 billion. The decision came after the FDA requested additional analyses during review, and the expanded indication positions Imcivree as the first approved therapy for this specific, rapidly progressive form of obesity.