Clinuvel granted orphan designation
Tuesday, 29 July, 2008
Clinuvel Pharmaceuticals' [ASX: CUV] lead compound afamelanotide (CUV1647) has been granted orphan-drug designation by the US FDA.
Afamelanotide is a photoreceptive drug designed for use in the management of erythopoietic porphyrias, a rare group of metabolic disorders which cause phototoxicity.
Orphan-drug designation allows for an accelerated review process by the FDA, seven-year exclusivity once approval is obtained, and various tax benefits and fee exemptions.
Afemelanotide is also being developed as a treatment for other UV-related skin disorders and for cancer prophylaxis.
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