Le médicament SCENESSE® du laboratoire Clinuvel, très attendu par les patients atteints de PPE, a reçu l’approbation de l’EMA. Toutefois, les modalités pratiques et la mise en oeuvre de cette décision ne sont pas encore connues.
En attendant la prochaine traduction en français, voici le communiqué officlel du laboratoire Clinuvel.
Dear friends and colleagues, Earlier today the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced the result of its scientific evaluation of Clinuvel’s drug SCENESSE® (afamelanotide 16mg) for adult patients diagnosed with erythropoietic protoporphyria (EPP). Based on its evaluation, the CHMP has issued a positive opinion under exceptional circumstances in compliance with EC Regulation 726/2004, Article 14(8).
Clinuvel’s teams appreciate that the EPP community may have several questions regarding the European regulatory outcome and its impact on the clinical availability of the drug and we will endeavour to provide as much information as is possible in due course. In the short term we have compiled answers to what we anticipate will be the most asked questions in the document attached.
I would appreciate you contacting me directly in the event that you are approached to discuss Clinuvel’s program by a third party. Remain aware that third parties may use your statements to speculate on the value of the Company.
On behalf of Clinuvel’s staff and management, I take this opportunity to thank you for your ongoing support of our program and welcome any further questions you may have.
Head of Global Network and Communications, Clinuvel Pharmaceuticals Ltd