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 (n=39) in pts with acquired HO
- Trial met its 1EP with a 19.8% PBO-adjusted reduction in BMI, showing -16.5% vs +3.3% mean BMI change from baseline at 52wks. Adults (n=49) showed 19.2% PBO-adjusted BMI reduction, while pediatric pts (n=71) achieved 20.2% decrease at 52wks.
Ref: Globenewswire| Image: Rhythm | Press Release
Related News: Rhythm Pharmaceuticals Reports the US FDA Approval of Imcivree (Setmelanotide) for Acquired Hypothalamic Obesity
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