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.

According to the company, Imcivree is the first and only precision medicine to target impairment of the hypothalamic MC4R pathway, a root cause of hyperphagia and obesity due to BBS and POMC, PCSK1 and LEPR deficiencies in adults and children as young as two years old in the USA as well as Europe.