setmelanotide injection
for subcutaneous use Initial U.S. Approval: 2020
IMCIVREE is a melanocortin 4 (MC4) receptor agonist 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).
Facts about setmelanotide injection
Approval Date: 2/17/2020
Proprietary Name: On Request
Active Ingredient(s): setmelanotide
FDA-approved use: chronic weight management
Medicine Approved By: – European Medical Agency (EMA), Food and Drug Administration (FDA),
Summary of FDA-approved use on approval date: Click Here
(see Drugs@FDA for complete indication)
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