RegulatoryMay 1, 2026, 06:57 AM
RYTM IMCIVREE® EC Authorization for Acquired Hypothalamic Obesity
AI Summary
Rhythm Pharmaceuticals, Inc. announced that the European Commission (EC) has expanded the marketing authorization for IMCIVREE® (setmelanotide) to treat obesity and control hunger in adults and children 4 years and above with acquired hypothalamic obesity (HO). This marks the first therapy to be EC-authorized for this rare neuroendocrine disease, which affects an estimated 10,000 people in Europe. The approval is based on positive Phase 3 TRANSCEND trial results, showing a statistically significant -19.8% placebo-adjusted reduction in BMI. The company anticipates commercial launches in Europe in 2027, following a prior U.S. FDA approval in March 2026.
Key Highlights
- EC expanded marketing authorization for IMCIVREE® (setmelanotide) for acquired hypothalamic obesity (HO).
- Authorization covers adults and children 4 years and above with acquired HO due to hypothalamic injury or impairment.
- Rhythm estimates approximately 10,000 people live with acquired HO in Europe.
- Pivotal Phase 3 TRANSCEND trial met primary endpoint with -19.8% placebo-adjusted BMI reduction.
- Commercial launches in Europe are anticipated in 2027.
- U.S. FDA approved IMCIVREE® for acquired HO on March 19, 2026.