Setmelanotide
Prepared by: Anshu Gupta, MD, MS and Brenda Kohn, MD
Up-to-date as of December 14, 2020
On November 27, 2020, setmelanotide (IMCIVREE™; Rhythm Pharmaceuticals, Inc.), a melanocortin-4 (MC4) receptor agonist, received U.S. Food & Drug Administration (FDA) approval for the treatment of three rare monogenic types of obesity: proopiomelanocortin (POMC ) deficiency, proprotein convertase subtilisin/kexin type 1 (PCSK1) deficiency, and leptin receptor (LEPR) deficiency. Setmelanotide is approved for genetically confirmed POMC, PCSK1, and LEPR deficiency for children 6 years of age or older and for adults, and is the first FDA-approved therapy for obesity due to these rare genetic causes.
