Summary

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• Imcivree (setmelanotide) is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS). The drug is also indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to Bardet-Biedl syndrome (BBS).
• This summary is based on the review of one systematic review(s)/meta-analysis(es). ^[1]
• Weight Loss: Setmelanotide is effective in promoting weight loss in patients with severe obesity linked to human MC4R deficiency, with a significant mean difference in weight loss of -3.52 (95% CI -3.98, -3.05) and an average weight reduction of -6.91% during the treatment period.
• Body Mass Index (BMI): Significant reductions in BMI were observed, with a mean difference of -10.55 kg/m² in patients older than 18 years and -0.61 kg/m² in patients younger than 18 years.
• Setmelanotide is associated with an increased risk of skin hyperpigmentation, with an odds ratio (OR) of 0.69 (95% CI 0.55, 0.80; p = 0.08).
• No age-specific safety outcomes are provided, and no comparisons to other drugs regarding safety are mentioned in the provided data.