Clinuvel submits Scenesse MAA to EMA
Clinuvel Pharmaceuticals has submitted its Scenesse's (afamelanotide 16mg implant) marketing authorisation application (MAA) to the European Medicines Agency (EMA).
Scenesse's MAA covers its use as a prophylactic treatment in adult patients with erythropoietic protoporphyria (EPP), a disease causing absolute intolerance of patients' skin to light.
Scenesse is a dissolvable implant, which when administered underneath the skin, activates eumelanin of the skin, the dark pigment which is known to provide photoprotective properties (offering skin protection against light and UV radiation).
Under the EMA's centralised procedure, Scenesse, will be reviewed which will allow Clinuvel to market Scenesse in all 27 European Union (EU) member states as well as Norway, Iceland and Liechtenstein.
Clinuvel CSO Hank Agersborg said they are confident that they have provided sufficient data to demonstrate that Scenesse is a safe and clinically meaningful treatment for EPP.
Clinuvel CEO Philippe Wolgen said in the coming months they will continue their constructive dialogue with the regulatory authorities to bring this much-needed therapy to the EPP community across Europe.
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