FDA nod for Rhythm Pharma’s Imcivree

The US Food and Drug Administration (FDA) on Friday approved an expanded indication for Imcivree (setmelanotide), from Boston, USA-based Rhythm Pharmaceuticals (Nasdaq: RYTM), to include children as young as two years old.

Rhythm said that Imcivree is indicated to reduce excess body weight and maintain weight reduction long-term in patients two years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency.