Clinuvel files for marketing approval for SCENESSE in Europe

Clinuvel Pharmaceuticals (ASX:CUV) has made a leap for the final regulatory hurdle in Europe and has submitted a marketing authorisation application with the European Medicines Agency (EMA) for its SCENESSE skin treatment.

Clinuvel has applied to be able to market SCENESSE in all 27 EU member states – plus Norway, Iceland and Liechtenstein – as a prophylactic treatment for erythropoietic protoporphyria (EPP).

Read more about Clinuvel and the SCENESSE technology.

The company was granted orphan drug status for SCENESSE by the EMA as well as the US Food and Drug Administration as an EPP treatment in 2008.

EPP is a rare genetic disease which causes absolute intolerance of patients’ skin to light. It affects around 10,000 people globally, with around 4,000 of these living in Europe.

Sufferers often exhibit mild to acute pain, swelling and scarring of exposed areas following light or UV exposure. There is presently no known effective treatment for the condition.

Clinical trials of SCENESSE as an EPP treatment have demonstrated that afamelanotide, the active ingredient, can reduce the severity of these symptoms.

Afamelanotide is a linear peptide which activates eumelanin in skin, providing light and UV radiation protection. The treatment is administered subdermally as a dissolvable implant.

The EMA will evaluate SCENESSE using its Centralised Procedure. Clinuvel CSO Dr Hank Agersborg said he was confident the company has submitted an application that will pass regulatory review.

Clinuvel (ASX:CUV) shares fell 1.35% on Tuesday to $2.200. The shares have been hovering around nine-month highs since a significant stock bump in January.