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US FDA sets target action date for Clinuvel's Scenesse new drug application

Clinuvel Pharmaceuticals Ltd. said the U.S. Food and Drug Administration set a July 8 target action date for its new drug application for Scenesse.

Scenesse is a potential treatment for a rare metabolic disorder known as erythropoietic protoporphyria, or EPP. It is characterized by photosensitivity, in which sun exposure causes itching, reddening, swelling, pain and even burns.

Also known as afamelanotide, Scenesse received orphan drug and fast-track status from the FDA in 2008 and 2016, respectively. The drug, which Clinuvel evaluated in five clinical trials, is approved in Europe to prevent phototoxicity in EPP patients.

Melbourne-based Clinuvel develops treatments for patients with severe genetic and skin disorders.