Abstract
Subcutaneous setmelanotide (IMCIVREE®), a melanocortin-4 receptor agonist, meets a previously unmet need and thus represents an important advancement in the management of patients with pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency obesity. Setmelanotide is the first approved treatment in patients aged ≥ 6 years with these conditions. In two single-arm, open-label, multicentre, phase III trials, subcutaneous setmelanotide was effective in reducing body weight by at least 10% from baseline after approximately 1 year of treatment at individualised therapeutic doses in patients aged ≥ 6 years with POMC, PCSK1 or LEPR deficiency obesity. Other outcomes relating to weight loss and self-reported hunger scores were also improved with setmelanotide therapy. Setmelanotide was generally well tolerated in clinical trials.
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