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EMA's CHMP gives positive opinion to expand IMCIVREE for treating acquired hypothalamic obesity

Market News
26 Mar 2026
GlobeNewsWire
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Bullish
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Rhythm Pharmaceuticals announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to expand the marketing authorization of IMCIVREE (setmelanotide) to treat obesity and control hunger in patients aged 4 and above with acquired hypothalamic obesity caused by hypothalamic injury or impairment. This follows recent FDA approval and addresses a significant unmet medical need for this rare neuroendocrine disease characterized by severe weight gain and insatiable hunger. The European Commission is expected to make a final decision in the second quarter of 2026. This expansion could provide a new treatment option for approximately 20,000 patients in the US and EU combined.

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