Imcivree® (setmelanotide) – Expanded indication
December 20, 2024 - Rhythm Pharmaceuticals announced the FDA approval of Imcivree (setmelanotide), to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 2 years and older with syndromic or monogenic obesity due to: (1) Bardet-Biedl syndrome (BBS) and (2) 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.