Rhythm’s IMCIVREE Wins CHMP Nod for Acquired Hypothalamic Obesity; EC Decision Q2
The EMA’s CHMP issued a positive opinion to expand IMCIVREE’s label to treat obesity and control hunger in adults and children aged four and above with acquired hypothalamic injury. The European Commission’s final decision is expected in the second quarter of 2026.
1. CHMP Positive Opinion for IMCIVREE
The Committee for Medicinal Products for Human Use adopted a positive opinion recommending an expanded marketing authorization for IMCIVREE in adults and children aged four years and older with acquired hypothalamic obesity due to injury or impairment of the hypothalamus.
2. Market Opportunity
Rhythm estimates approximately 10,000 individuals in both the United States and the European Union live with acquired hypothalamic obesity, representing a combined addressable population of roughly 20,000 patients who could benefit from IMCIVREE’s targeted treatment.
3. Regulatory Timeline
Following the CHMP’s recommendation, the European Commission will review the opinion and is set to render its final decision on the expanded indication in the second quarter of 2026.
4. Global Strategy
This European advancement follows recent U.S. approval for the same indication, demonstrating Rhythm’s coordinated global approach to commercialize setmelanotide for rare neuroendocrine obesity disorders and support long-term weight management.