Drug updated on 4/17/2024
| Dosage Form | Injection (subcutaneous: 10 mg/mL) |
| Drug Class | Melanocortin receptor agonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).
- Indicated for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to Bardet-Biedl syndrome (BBS).
Summary
- Setmelanotide (Imcivree) is a drug used for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance.
- The medication is also indicated for the treatment of obesity resulting from Bardet-Biedl syndrome.
- A systematic review/meta-analysis was conducted on setmelanotide's efficacy and safety profile; this included data from both randomized and nonrandomized clinical trials involving a total population of 376 patients who were followed up over an average period of one year.
- Significant weight loss was observed among the participants receiving setmelanotide during the study period; there was an average proportionate reduction in body mass index by -10.55 kg/m² among adults (>18 years old) while children (<18 years old) experienced a decrease by -0.61 kg/m² BMI score.
- Despite its effectiveness at promoting weight loss, use of setmelanotide has been associated with increased risk for skin hyperpigmentation according to statistical analysis results derived from these studies.
- Overall findings suggest that despite some side effects such as skin hyperpigmentation risks which need further investigation, setmelanotide can be considered effective at managing severe forms of genetically-linked obesity conditions based on current evidence available.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Imcivree (setmelanotide) Prescribing Information. | 2022 | Rhythm Pharmaceuticals, Inc., Boston, MA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy and Safety of Setmelanotide, a Melanocortin-4 Receptor Agonist, for Obese Patients: A Systematic Review and Meta-Analysis. | 2023 | Journal of personalized medicine |
| Setmelanotide for treating obesity caused by LEPR or POMC deficiency. | 2022 | NICE |
| Assessment report: Imcivree. | 2021 | EMA |