EMA Recommends Rhythm Pharma’s Expanding IMCIVREE® Approval For Hypothalamic Obesity Treatment

Rhythm Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending the expansion of the marketing authorisation for IMCIVREE® (setmelanotide). The proposed label expansion covers the treatment of obesity and hunger control in adults and children aged four years and older with acquired hypothalamic obesity.

The CHMP’s recommendation will now be reviewed by the European Commission, which has the final authority to grant or extend marketing approvals across the European Union. A decision is expected in the second quarter of 2026.

“The positive CHMP opinion with a broad label following closely upon last week's FDA approval validates the quality of the data which supports our filings in acquired HO and further confirms our global approach to drug development,” said David Meeker, M.D., Chairman, President and Chief Executive Officer of Rhythm. “Acquired HO represents a significant unmet medical need across geographies and a unique opportunity for Rhythm, which we are well-positioned to execute on.”

Acquired hypothalamic obesity is a rare neuroendocrine disorder caused by damage or dysfunction of the hypothalamus, often resulting from tumours, brain injury, or other medical conditions. This disruption affects the MC4R pathway, which plays a critical role in regulating appetite, energy balance, and body weight, leading to rapid, sustained weight gain and excessive hunger.

“Acquired hypothalamic obesity is a devastating neuroendocrine disease characterised by reduced energy expenditure, hyperphagia (pathological insatiable hunger) and accelerated, sustained weight gain resulting from physical injury or structural abnormality of the hypothalamus. This disease condition is driven by impairment of the MC4R pathway signalling and other hypothalamic functional damage, making it exceptionally difficult to manage with existing approaches,” said Professor Hanneke van Santen, M.D., PhD., professor of pediatric endocrinology at the Prinses Máxima Centre and Wilhelmina Children’s Hospital, Utrecht, The Netherlands. “There is a clear and urgent need for a precision medicine that targets the root cause of the disease and offers patients a meaningful path forward.”

Rhythm Pharmaceuticals estimates that approximately 10,000 individuals in both the United States and the European Union are affected by this condition, highlighting a significant unmet need that IMCIVREE® aims to address if the expanded indication is approved.