Is Setmelanotide legal in United Kingdom?

Setmelanotide (Imcivree, Rhythm Pharmaceuticals) has a UK marketing authorisation (PLGB 55587/0001). The MHRA's orphan register (September 2026) lists it for obesity and hunger caused by genetically confirmed POMC (including PCSK1) or LEPR deficiency and for Bardet-Biedl syndrome, in people aged 2 and over, and for acquired hypothalamic obesity in people aged 4 and over. NICE highly specialised technologies guidance HST21 (July 2022) recommends it on the NHS, within its marketing authorisation, for POMC (including PCSK1) or LEPR deficiency in people aged 6 and over, only under the company's commercial arrangement. It is a prescription-only treatment for these rare conditions, not a general weight-loss medicine. We did not check NICE guidance for its other licensed uses.