Thursday, March 13, 2014

EMA’s review of SCENESSE® extended to mid-2014

EMA’s review of SCENESSE® extended to mid-2014

Melbourne, Australia and Baar, Switzerland, January 30, 2014

Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that the European Medicines Agency has extended the marketing authorisation application (MAA) review period for its drug SCENESSE® (afamelanotide 16mg implant) to mid-2014. Clinuvel’s MAA for SCENESSE® is aimed at a preventative treatment of the orphan (rare) light-intolerance disorder, erythropoietic protoporphyria (EPP) in adult patients. Clinuvel filed the MAA with the Agency in February 2012.
“The review of a first-in-class drug, albeit for an untested disease in which light exposure plays a dominant role, was always going to be subject of a lengthy regulatory review,” Clinuvel’s acting Chief Scientific Officer, Dr Dennis Wright said. “In this case, the Agency has requested additional time to review the clinical data of the US Phase III study in EPP (CUV039) study which was submitted last year. The evaluation clock has been stopped until June 2014. During this time the company will work with the EMA to address any further questions which may arise.”
“The company has much confidence in the EMA’s approach to learn as much as possible about the clinical aspects of the disease and the clinical relevance of the treatment to patients,” Clinuvel’s CEO, Dr Philippe Wolgen said. “This extended review period will also allow time for EPP patients and expert physicians to share their experience with the EMA.”

 Clinuvel Pharmaceuticals Limited

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