FDA Approval of setmelanotide (Imcivree) for chronic weight management in patients with obesity due to POMC, PCSK1 or LEPR deficiency
Approval is based on phase III clinical data which showed that 80% of patients with obesity due to POMC or PCSK1 deficiency achieved >10% weight loss and 45.5% of patients with obesity due to LEPR deficiency achieved >10% weight loss after one year of treatment.
Source:
US Food and Drug Administration
SPS commentary:
Setmelanotide is a melanocortin-4 receptor(MC4R) agonist. MC4R is part of key biological pathway regulating energy expenditure & appetite. POMC & LEPR deficiency obesities are ultra-rare genetic disorders, with patients suffering from insatiable hunger beginning at very young age.
A Marketing Authorization Application has been submitted to European Medicines Agency for setmelanotide as treatment of POMC and LEPR deficiency obesities.