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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.