28 October 2014 - The European Medicines Agency has approved Australia-based Clinuvel Pharmaceuticals' Scenesse (afamelanotide 16mg) drug to treat adult patients with rare skin disorder, erythropoietic protoporphyria, it was reported yesterday.

The firm stated that the product acts as an anti-oxidant and activates melanin in the skin and is the first treatment that has been developed for this skin disorder.

The product has received approval based on clinical trials conducted in 350 adult erythropoietic protoporphyria patients. The trial indicated that the drug is well tolerated and reduces the incidence and severity of reactions. The European Medicines Agency's committee for Medicinal Products for Human Use has recommended that the product be approved under exceptional circumstances that will allow the company to market the drug for the disease across the European states. Both parties have agreed to a comprehensive post-authorisation pharmacovigilance plan to follow up patients based on the exceptional circumstances approval.