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 BMI change from baseline at 52wks., plus demonstrated favorable safety
Ref: Rhythm | Image: Rhythm | Press Release
Related News: Rhythm Pharmaceuticals Reports Topline Data from P-III (TRANSCEND) Trial of Setmelanotide for Acquired Hypothalamic Obesity
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