Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it has submitted a marketing authorisation application (MAA) for its first-in-class drug SCENESSE® (afamelanotide 16mg implant) to the European Medicines Agency (EMA). The MAA covers the use of SCENESSE® as a prophylactic treatment in adult patients with erythropoietic protoporphyria (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. 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.
"We are confident that we have provided sufficient data to demonstrate that SCENESSE® is a safe and clinically meaningful treatment for EPP," Clinuvel's Chief Scientific Officer, Dr Hank Agersborg said. "We firmly believe that our application will withstand the rigor of the regulatory review."
"This filing is an important milestone in the evolution of Clinuvel, and is another landmark among the innovative therapies developed by the biotech sector, as afamelanotide is the first ever melanocortin filed for marketing approval," Clinuvel's CEO, Dr Philippe Wolgen said. "In the coming months we will continue our constructive dialogue with the regulatory authorities in order to bring this much-needed therapy to the EPP community across Europe."
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