Overview
- The expanded indication makes setmelanotide the first U.S.-approved treatment for obesity caused by hypothalamic injury.
- Rhythm says Imcivree is available immediately in the United States as a once-daily injection that targets the MC4R pathway to reduce hunger and increase energy expenditure.
- A Phase 3 study in 142 patients met its primary goal with an 18.4% placebo‑adjusted BMI reduction, reflecting a 15.8% drop on therapy versus a 2.6% rise on placebo at 52 weeks.
- The label covers adults and children 4 years and older with acquired hypothalamic obesity, and the company estimates about 10,000 people in the U.S. have the condition.
- Rhythm shares gained about 6% premarket as an analyst projected 2026 Imcivree sales of $290 million, including $34 million from the newly added indication.