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news.The European Medicines Agency (EMA) agreed with Clinuvel Pharmaceuticals' tentative dossier for the novel drug afamelanotide (SCENESSE) submission period of the last quarter of 2011 for the orphan designated disease erythropoietic protoporphyria (EPP), following its pre-submission meeting with the company on 5 May.
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SCENESSE, an injectable implant formulation of the drug afamelanotide, administered every 60 days, mimics the body’s natural ability to activate melanin in the skin.
In the pre-submission meeting the EMA evaluated whether the company had followed scientific advice provided in 2009 and asked Clinuvel to justify any deviations from this advice in its final dossier.
The EMA recommended that a Good Manufacturing Practice (GMP) audit be initiated by the company to facilitate the review process and confirmed that, since EPP is an orphan indication, no application fees will be payable.
EMA’s approval through the CP would allow Clinuvel to market afamelanotide under the brand name SCENESSE in all 27 European Union member states as well as Norway, Iceland and Liechtenstein.
Clinuvel chief scientific officer Hank Agersborg said the two confirmatory EPP studies CUV029 and CUV030 will be pivotal in the assessment of further efficacy and safety, the most important prerequisite for a successful submission.
Clinuvel CEO Philippe Wolgen said subject to positive results in the CUV029 and CUV030 trials, they will be able to submit efficacy data for 250 EPP patients and safety data for 450 additional photodermatoses patients evaluated across the clinical program.