20 December 2024 - Rhythm Pharmaceuticals today announced that the US FDA has approved an expanded indication for Imcivree (setmelanotide) to include children as young as 2 years old.
Imcivree is indicated to reduce excess body weight and maintain weight reduction long-term in patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome or genetically confirmed pro-opiomelanocortin, including proprotein convertase subtilisin/kexin type 1, deficiency or leptin receptor deficiency.