Clinuvel still waiting for drug approval Drug developer Clinuvel Pharmaceuticals says it is taking longer than expected for European regulators to approve its drug to treat a rare and painful skin disorder caused by intolerance to light. Patients with erythropoietic protoporphyria (EPP) suffer phototoxicity of the skin, experiencing great pain, swelling and scarring, often on exposed areas such as the face, hands and feet. They are often forced to live a sheltered life indoors to avoid exposure to light. The Clinuvel treatment, referred to as Scenesse, is a photoprotective drug that increases levels of melanin in the skin and shields against UV radiation and sunlight. The photoprotective drug, afamelanotide, is delivered via an implant about the size of a grain of rice placed under the skin, where it dissolves. Clinuvel applied for European marketing authorisation for Scenesse in February 2012. Clinuvel managing director Philippe Wolgen said, in a letter to shareholders on Wednesday, that Clinuvel was still awaiting the outcome of the European Medicines Agency's (EMA) review of Scenesse. This process has taken longer than any of us could have anticipated. However, we welcome the agency's tenacity to ensure the drug is given proper evaluation and patients and physicians are given the opportunity to be heard," Dr Wolgen said. Clinuvel said at its annual general meeting in November 2013 that the EMA's evaluation of Scenesse was one of the three longest ongoing reviews in the agency's history. The EMA was assessing whether the benefits of the drug outweighed the risk to patients, and whether the drug would enable patients to do things they could not do before. Clinuvel has said that afamelanotide is the first in the class of melanocortin drugs to proceed so far through the clinical and regulatory framework. "The lengthy EMA review is perhaps indicative of the complexity of evaluating the first melanocortin as a viable therapy," Dr Wolgen said in his letter to shareholders on Wednesday. He said Clinuvel would finalise the development of a Scenesse formulation for children suffering EPP when EMA approval of Scenesse was confirmed. Shares in Clinuvel were steady at $1.30 at market close on Wednesday.