Clinuvel receives IND status

By Kate McDonald
Thursday, 29 January, 2009

Melbourne’s Clinuvel has received investigational new drug (IND) status for its photoprotective drug afamelanotide from the US FDA.

The ruling will allow the company to begin clinical trials in the US. It received orphan drug designation from the FDA in July last year.

Afamelanotide is currently in Phase III trials for the treatment of erythropoietic protoporphyria (EPP) in Europe and Australia, amongst several other trials in UV-related skin disorders.

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