Shots:
- The US FDA has accepted sNDA of setmelanotide for the treatment of conditions associated with acquired hypothalamic obesity (PDUFA: Dec 20, 2025); Type II variation MAA is under the CHMP’s review
- sNDA & MAA were supported by global P-III (TRANSCEND) trial (N=120) assessing setmelanotide (n=81) vs PBO (n= 39) in 49 adults & 71 pediatric pts; additional arm of 12 Japanese pts is ongoing, with topline data expected by Q1’26
- Trial met its 1EP with a -19.8% PBO-adjusted reduction in BMI & showed -16.5% vs +3.3% mean BMI change at 52wks. as well as -19.2% & -20.2% PBO-adjusted BMI reductions in adult & pediatric pts, respectively; data was presented at ENDO 2025
Ref: Rhythm Pharmaceuticals | Image: Rhythm Pharmaceuticals | Press Release
Related News:- Rhythm Pharmaceuticals Reports Topline Data from P-III (TRANSCEND) Trial of Setmelanotide for Acquired Hypothalamic Obesity
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
