Setmelanotide

(Imcivree®)

Imcivree®

Drug updated on 5/17/2024

Dosage FormInjection (subcutaneous; 10 mg/mL)
Drug ClassMelanocortin 4 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 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).
  • 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).

Latest News

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Summary
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  • Setmelanotide (Imcivree) is indicated for chronic weight management in adults 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), leptin receptor (LEPR) deficiency, or Bardet-Biedl syndrome.
  • The information was derived from a single study in the category of Systematic Reviews / Meta-Analyses.
  • Imcivree has demonstrated significant efficacy in weight loss among patients with severe obesity associated with MC4R deficiency. The mean weight loss observed was substantial, averaging -6.91% during the treatment period.
  • There is an age-related variability in response to therapy; adults experienced a greater impact than pediatric patients, evidenced by a mean difference in Body Mass Index scores of -10.55 kg/m^2 versus -0.61 kg/m^2, respectively.
  • A potential side effect noted for Imcivree is skin hyperpigmentation, which may differ from other treatments' profiles, making it stand out as a specific safety consideration for this medication.
  • Efficacy results underscore the importance of genetic testing and personalized medicine in obesity treatment. Populations suffering from POMC, PCSK1, LEPR deficiencies, or Bardet-Biedl syndrome have shown pronounced effectiveness when treated with Imcivree compared to traditional methods for genetically induced obese conditions.

Product Monograph / Prescribing Information

Document TitleYearSource
Imcivree (setmelanotide) Prescribing Information.2023Rhythm Pharmaceuticals, Inc., Boston, MA

Systematic Reviews / Meta-Analyses