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Clinuvel's photosensitivity drug approved by US FDA after extended review

The U.S. Food and Drug Administration has approved Clinuvel Pharmaceuticals Ltd.'s photosensitivity drug Scenesse after an extended review of the therapy.

Scenesse, or afamelanotide, is used to increase pain-free light exposure in adults who have a history of damage to skin resulting from the rare disorder erythropoietic protoporphyria. The FDA said in an Oct. 8 press release that patients with the disorder experience extremely painful reactions when exposed to light and can even experience burns from exposure.

The regulator said before Scenesse, the disorder had no approved treatments to help adult patients increase their exposure to light.

Shares of the Australian company jumped 30% to US$24 as of 3:22 p.m. ET.

Clinuvel was originally expected to receive a response on Scenesse from the FDA in July, but the review was extended when the agency said it needed more time.

Scenesse is an implant delivered under the skin that increases the body's production of a type of skin pigment called eumelanin. The therapy 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 patients with erythropoietic protoporphyria.