Rhythm Pharmaceuticals’ Imcivree granted MAA in Europe for obesity

Rhythm Pharmaceuticals (RYTM) announced the European Commission, or EC, has expanded the marketing authorization for Imcivree – setmelanotide – to include the treatment of obesity and control of hunger in adults and children 4 years of age and above with acquired hypothalamic obesity, or HO, due to hypothalamic injury or impairment. Acquired HO is a rare neuroendocrine disease characterized by accelerated and sustained weight gain caused by hypothalamic injury or impairment. Rhythm estimates there are approximately 10,000 people living with acquired HO in Europe. The EC approval is based on results from the Phase 3 TRANSCEND trial of setmelanotide in acquired HO. The global study met its primary endpoint. Setmelanotide was generally well tolerated in the TRANSCEND study. With EU authorization in place, The company will now work to secure access on a country-by-country basis across Europe. Commercial launches are anticipated in 2027. The company’s supplemental New Drug Application was approved by the FDA on March 19 for Imcivree to treat patients in the U.S. living with acquired HO.