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

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[{"type":"text","content":"-- European Commission decision anticipated in second quarter of 2026 -- BOSTON, March 26, 2026 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending to expand the current marketing authorization for IMCIVREE® (setmelanotide) to include the treatment of obesity and the control of hunger in adults and children 4 years of age and above with acquired hypothalamic obesity (HO) due to hypothalamic injury or impairment. “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 devastating neuroendocrine disease characterized 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 MC4R pathway signaling 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 Center 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 offer patients a meaningful path forward.” The CHMP opinion will now be reviewed by the European Commission (EC), which has the authority to grant and expand marketing authorizations for medicinal products in the European Union. A final decision is anticipated in the second quarter of 2026. About Acquired Hypothalamic Obesity Acquired hypothalamic obesity is a rare neuro endocrine disease characterized by accelerated and ...

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