US FDA has approved Setmelanotide for patients with obesity due to POMC, PCSK1 or LEPR deficiency

Rhythm Pharmaceuticals have just announced that the U.S. Food and Drug Administration (FDA) has approved IMCIVREE™ (setmelanotide), which is a MC4R agonist, for the treatment of adult and paediatric patients (aged over 6 years) with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. This is great news for patients with these disorders and comes on the back of recent successful clinical trials led by our team in Cambridge in collaboration with colleagues across Europe and the US. The company are in the process of applying for approval in Europe. We are also running clinical trials to see if Setmelanotide may work in people with other genetic conditions that affect the same pathway.

For further information, the press release from Rhythm can be found here.