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.