US FDA Approval

Clinuvel, an SJE Group investment, has received US Food & Drug Administration (FDA) approval to market SCENESSE® (afamelanotide 16mg) for the treatment of the rare metabolic disorder erythropoietic protoporphyria (EPP) in the US.

This makes SCENESSE® the first global systemic photoprotective drug for the treatment of patients with EPP.

SCENESSE® acts as a potent anti-oxidative and melanogenic agent providing pandermal (total surface) photoprotection. This genetic disorder causes absolute light intolerance and forces patients to lead an indoor or nocturnal existence. Due to a defect in heme biosynthesis, EPP patients accumulate and store the compound protoporphyrin IX (PPIX) in the blood and tissues. When exposed to visible light and near- visible ultraviolet radiation, PPIX is photoactivated, causing damage to surrounding tissue and resulting in intolerable pain.

SCENESSE® was approved for the prevention of phototoxicity in adult EPP patients in Europe in December 2014

SCENESSE® for treatment of EPP

Under the approved labelling of SCENESSE® , the drug is indicated to “increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)”.

The approved labelling covers all written material about the drug, including, for example, packaging, prescribing information for physicians, and patient information leaflets. The approved frequency and strength of dosing of SCENESSE® is 16 mg once every two months.

The SJE Group congratulates Dr Philippe Wolgen (Chief Executive Officer), Dr Dennis Wright (Chief Scientific Officer) and the rest of the Clinuvel team for this huge achievement.

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