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CHMP recommends Clinuvel's Scenesse

October 25, 2014 12:56 AM UTC

EMA's CHMP recommended marketing authorization under exceptional circumstances for Scenesse afamelanotide from Clinuvel Pharmaceuticals Ltd. (ASX:CUV; Xetra:UR9) to treat phototoxicity in patients with erythropoietic protoporphyria (EPP), a disorder characterized by extreme sensitivity to sunlight.

Scenesse is the first compound in EMA's pilot project to involve patients in CHMP's assessment of benefits and risks. The committee said its recommendation was based in part on reports from patients that Scenesse improved their quality of life, although the compound's benefits were difficult to assess because placebo-controlled trials are difficult to conduct. There is no other approved treatment (see BioCentury Extra, Nov. 11, 2013). ...