EMA Backs Rhythm's Obesity Drug for Rare Hypothalamic Condition

Rhythm Pharmaceuticals has received a positive recommendation from the European Medicines Agency (EMA) for its obesity drug. The Committee for Medicinal Products for Human Use (CHMP) backed expanding the use of IMCIVREE® to treat acquired hypothalamic obesity, a rare condition linked to severe weight gain. The decision now moves to the European Commission for final approval. IMCIVREE®, a drug already approved in the U.S. and EU for genetic obesity disorders, targets hyperphagia and extreme weight gain. It works as an MC4R agonist, addressing the root causes of obesity tied to genetic or hypothalamic dysfunction. The CHMP's opinion specifically covers adults and children aged four and above suffering from acquired hypothalamic obesity (HO), a condition caused by hypothalamic damage.

Estimates suggest around 20,000 to 50,000 people globally live with this disease, including roughly 10,000 each in the U.S. and EU. Professor Hanneke van Santen, a paediatric endocrinologist, described it as a devastating neuroendocrine disorder in urgent need of targeted treatment.

Rhythm's CEO, David Meeker, M.D., called the CHMP's opinion a validation of the company's global drug development strategy. The final EU decision on expanded marketing authorisation is expected by the second quarter of 2026. The CHMP's recommendation marks a key step toward broader access to IMCIVREE® for patients with acquired hypothalamic obesity. If approved by the European Commission, the drug could offer a new precision medicine option for a condition currently lacking effective treatments. Rhythm Pharmaceuticals, based in Boston, focuses on rare neuroendocrine diseases and continues to advance therapies for unmet medical needs.