Shots:
The EC has approved label expansion of Imcivree to incl. treatment of obesity & control of hunger in pts (≥4yrs.) with acquired hypothalamic obesity (HO) due to hypothalamic injury or impairment; commercial launch is expected in 2027
Approval was supported 120-patient cohort data from the global P-III (TRANSCEND) trial assessing setmelanotide (n=81) vs PBO…
Shots:
The US FDA has approved Imcivree for the treatment of pts (≥4yrs.) with acquired hypothalamic obesity (HO)
Approval was supported by the global P-III (TRANSCEND) trial assessing setmelanotide (n=94) vs PBO (n=48) in 142 pts with acquired HO
Trial met its 1EP with a 18.4% PBO-adjusted reduction in BMI, showing -15.8% vs +2.6% mean…

