New erythropoietic protoporphyrin (EPP) new drug Scenesse listing application for submission of EMA

Clinuvel Pharmaceuticals submitted a marketing application (MAA) for Scenesse to the European Medicines Agency (EMA). Scenesse applied for the treatment of adult erythropoietic protoporphyrin (EPP), a form of skin photophobia.

Scenesse is a soluble transplant that works from under the skin to activate skin melanin. Melanin provides photoprotective properties that protect the skin from light and ultraviolet radiation.

According to the EMA approval process, Scenesse will be sold in 27 EU countries including Norway and Liechtenstein in Iceland.

CSOHank Agersborg of Clinuvel said: “We are very confident about this application because we have provided sufficient experimental data and we believe that it is possible to prove that Scenesse is a safe and effective drug for the treatment of EPP.”

Clinuvel CEOOPHilippe Wolgen said: "In the next few months we will continue to engage in constructive dialogue with the Commission's authorities to quickly sell the drugs that are urgently needed by patients in the EU countries."