Imcivree FDA Approval History
Last updated by Judith Stewart, BPharm on June 16, 2022.
FDA Approved: Yes (First approved November 25, 2020)
Brand name: Imcivree
Generic name: setmelanotide
Dosage form: Injection
Company: Rhythm Pharmaceuticals, Inc.
Treatment for: Weight Loss (Obesity/Overweight)
Imcivree (setmelanotide) is a melanocortin 4 (MC4) receptor agonist for chronic weight management of obesity caused by proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency; or Bardet-Biedl syndrome.
- Imcivree 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).
- Bardet-Biedl syndrome (BBS).
- Imcivree is administered subcutaneously once daily.
- Imcivree warnings and precautions include disturbance in sexual arousal, depression and suicidal ideation, and skin pigmentation and darkening of pre-existing nevi.
- Common adverse reactions include skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection.
Development timeline for Imcivree
Further information
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