Rhythm Pharmaceuticals Receives Positive CHMP Opinion for IMCIVREE® (setmelanotide) for the Treatment of Obesity and Control of Hunger in Patients with Acquired Hypothalamic Obesity due to Hypothalamic Injury or Impairment

Core Viewpoint - Rhythm Pharmaceuticals has received a positive opinion from the European Medicines Agency's CHMP to expand the marketing authorization for IMCIVREE® (setmelanotide) to treat obesity and control hunger in patients aged 4 and above with acquired hypothalamic obesity, with a final decision expected in Q2 2026 [1][2] Group 1: Company Overview - Rhythm Pharmaceuticals is a commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases, with its lead product IMCIVREE® approved in the U.S. for treating acquired hypothalamic obesity and other genetic obesity syndromes [4][5] - The company is advancing a broad clinical development program for setmelanotide and other investigational MC4R agonists, as well as preclinical small molecules for congenital hyperinsulinism [4] Group 2: Acquired Hypothalamic Obesity - Acquired hypothalamic obesity is characterized by accelerated weight gain due to hypothalamic injury, leading to reduced energy expenditure and hyperphagia, with an estimated 10,000 patients in both the U.S. and EU affected by this condition [3] - The condition often follows the treatment of hypothalamic-pituitary tumors and is driven by impairment of the MC4R pathway, indicating a significant unmet medical need for effective treatments [3][2] Group 3: Regulatory Developments - The positive CHMP opinion follows recent FDA approval, reinforcing the quality of data supporting Rhythm's filings for acquired hypothalamic obesity and highlighting the company's global drug development strategy [2] - The European Commission will review the CHMP opinion, with a final decision anticipated in the second quarter of 2026, which could expand the market for IMCIVREE in the EU [1][2]