Rhythm Pharmaceuticals gets EU approval for obesity drug IMCIVREE

Rhythm Pharmaceuticals Inc. (NASDAQ: RYTM) announced the European Commission has expanded marketing authorization for IMCIVREE (setmelanotide) to treat obesity and control hunger in adults and children 4 years and older with acquired hypothalamic obesity due to hypothalamic injury or impairment.

The approval makes IMCIVREE the first therapy to receive both FDA approval and European Commission authorization for acquired hypothalamic obesity, according to the company's statement. Rhythm estimates approximately 10,000 people live with acquired hypothalamic obesity in Europe.

The European Commission authorization is based on results from a Phase 3 TRANSCEND trial involving 120 patients with acquired hypothalamic obesity. The study met its primary endpoint with a statistically significant 19.8% placebo-adjusted reduction in body mass index. Participants receiving setmelanotide achieved a 16.5% BMI reduction compared with a 3.3% increase among placebo patients at 52 weeks.

Adult patients achieved a 19.2% placebo-adjusted BMI reduction at 52 weeks, while pediatric patients achieved a 20.2% placebo-adjusted BMI reduction. The most common adverse events affecting more than 20% of participants were nausea, vomiting, diarrhea, injection site reaction, skin hyperpigmentation and headache.

Rhythm will work to secure access on a country-by-country basis across Europe, with commercial launches anticipated in 2027. The FDA approved the company's supplemental new drug application for IMCIVREE to treat acquired hypothalamic obesity in the United States on March 19, 2026.

Acquired hypothalamic obesity is a rare neuroendocrine disease characterized by accelerated weight gain caused by hypothalamic injury or impairment, most frequently following growth or treatment of craniopharyngioma, astrocytoma or other hypothalamic-pituitary tumors.

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