CUV 0.29% $14.00 clinuvel pharmaceuticals limited

(Adds details on the disorder) Oct 8 (Reuters) - The U.S. Food...

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    (Adds details on the disorder)

    Oct 8 (Reuters) - The U.S. Food and Drug Administration said on Tuesday it approved Australian drugmaker Clinuvel Pharmaceuticals Ltd's (CUV) treatment for a rare inherited disorder that results in skin damage from exposure to light.

    The treatment, Scenesse, is an under-the-skin implant that treats erythropoietic protoporphyria, a painful disorder that causes the skin to itch, burn, and scar in some rare cases, when exposed to sunlight and some types of artificial light.

    Scenesse is already approved in Europe since 2014 and is prescribed to patients through specialized treatment centers. It is the company's only approved treatment and brought in 25.8 million Australian dollars ($17.41 million) in 2018.

    The disorder, which affects one in 75,000 to 200,000 worldwide and has no approved treatment in the United States, can force patients to cover up their exposed skin and in some cases avoid daytime altogether, much like fictional vampires.

    Scenesse has shown to help patients stay outdoors longer without experiencing painful reactions to the sunlight.

    The disease results from a genetic mutation that causes accumulation of a chemical compound called protoporphyrin in the blood and the skin, making them sensitive to light.

 
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