Shots:
- The MHLW has approved Imcivree (setmelanotide) for pts (≥4yrs.) with acquired hypothalamic obesity (HO); commercial launch is expected by end of 2026, pending final pricing determination
- Approval was backed by the P-III (TRANSCEND) trial assessing Imcivree in 142 pts with acquired HO, incl. Japanese (n=12) & supplemental pts (n=10), which met its 1EP with a statistically significant 18.8% PBO-adjusted reduction in BMI; data were published in The NEJM
- Imcivree, an MC4R agonist granted orphan drug designation by Japan’s MHLW in March 2025, is the first therapy approved in Japan for treating acquired hypothalamic obesity (HO)
Ref: Globenewswire | Image: Rhythm | Press Release
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