Clinuvel Pharmaceuticals (ASX:CUV) said the European Medicines Agency (EMA) agreed to amend the label for Scenesse, or afamelanotide, removing the recommended maximum annual dose of four implants per year, allowing adult erythropoietic protoporphyria patients to receive treatment every two months, according to a Tuesday Australian bourse filing.

Erythropoietic protoporphyria is a genetic disorder characterized by sensitivity to sunlight or artificial light, irritating the skin.

The EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the benefit-risk profile of year-round treatment with scenesse after engagement with the firm's team.

The committee looked at data from two phase three studies and real-world evidence from over 15 years, including a review of the safety and effectiveness profile of Scenesse in European patients who have received four or more implants in any one calendar year. It concluded that there were no significant safety concerns with the ongoing administration of the drug every two months.