FDA approves Scenesse for the rare dermatology disorder of erythropoietic protoporphyria. - Clinuvel Pharmaceuticals

Clinuvel Pharmaceuticals Ltd. has worked for more than a decade to bring Scenesse (afamelanotide) to the US market for the rare dermatology disorder erythropoietic protoporphyria (EPP), an effort that concluded on 8 October with a delayed approval by the FDA. A melanocortin-1 receptor (MC1-R) agonist, Scenesse obtained clearance by the European Medicines Agency in 2014 and launched in 2016, with business in Germany primarily driving growth. In August, Clinuvel reported $31m in sales for the product over the 12 months ending 30 June, a 21.8% increase. In the UK, an initial rejection by NICE of including the drug in the National Health Service formulary has been under review since last October.

The active substance in Scenesse, afamelanotide, is similar to a hormone in the body known as alpha-melanocyte stimulating hormone, which stimulates the production of a brown-black pigment in the skin. This pigment, known as eumelanin, is produced during exposure to sunlight to block the penetration of light into cells. Patients with EPP have high levels of a substance called protoporphyrin IX in the body. Protoporphyrin IX is phototoxic and, when exposed to light, causes the painful reactions seen with this condition. By stimulating the production of eumelanin in the skin, Scenesse reduces the penetration of light through the skin, thus helping to prevent the painful reactions.