Clinuvel Pharmaceuticals Limited (VLVLY.PK) Monday announced that it has submitted a marketing authorisation application, or MAA, for its first-in-class drug SCENESSE to the European Medicines Agency, or the EMA.
The company stated that the MAA covers the use of SCENESSE as a prophylactic treatment in adult patients with erythropoietic protoporphyria, or EPP, a rare disease which causes absolute intolerance of patients' skin to light.
SCENESSE, which received an orphan drug designation for EPP in 2008, will be reviewed under the EMA's Centralised Procedure.
The Company further added an approval under this scheme will allow Clinuvel to market SCENESSE in all 27 European Union member states as well as Norway, Iceland and Liechtenstein.
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