Rhythm Pharmaceuticals’ Imcivree Receives Expanded UK Authorization for Hypothalamic Obesity

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…

ByRidhi Rastogi2 days ago

Rhythm Pharmaceuticals Reports the EC Approval of Imcivree (Setmelanotide) for Acquired Hypothalamic Obesity

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…

ByRidhi RastogiMay 4, 2026

Rhythm Pharmaceuticals Reports the US FDA Approval of Imcivree (Setmelanotide) for Acquired Hypothalamic Obesity

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…

ByRidhi RastogiMarch 20, 2026

Rhythm Pharmaceuticals’ Imcivree Receives Expanded UK Authorization for Hypothalamic Obesity

Rhythm Pharmaceuticals Reports the EC Approval of Imcivree (Setmelanotide) for Acquired Hypothalamic Obesity

Rhythm Pharmaceuticals Reports the US FDA Approval of Imcivree (Setmelanotide) for Acquired Hypothalamic Obesity

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