Shots:
- The MHRA has expanded market authorization for Imcivree (setmelanotide) to incl. the treatment of obesity & control of hunger in pts (≥4yrs.) with acquired hypothalamic obesity due to hypothalamic injury or impairment
- Approval was backed by the global P-II/III (TRANSCEND) trial assessing Imcivree vs PBO in 120 pts with acquired HO, meeting its 1EP with a 19.8% PBO-adjusted reduction in BMI, showing -16.5% vs +3.3% mean BMI change from baseline at 52wks.
- At Wk. 52, Imcivree achieved PBO-adjusted BMI reductions of 19.2% in adults (n=49) & 20.2% in pediatric pts (n=71), with pts also reporting reduced hunger; data were published in The NEJM
Ref: Globenewswire | Image: Rhythm | Press Release
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