Since 2006, Clinuvel’s focus has been to develop and commercialise SCENESSE® (INN: afamelanotide) as a medicinal photoprotective solution for patients who are most severely affected by ambient light exposure and UV. Erythropoietic protoporphyria (EPP) was identified as a most severe disorder affecting adult and juvenile patients. Following positive results from Phase II and III trials of the drug in EPP, Clinuvel filed its first Marketing Authorisation Application (MAA) for SCENESSE® in Europe in February 2012. This is expected to be followed by filings in Switzerland, Australia and the USA.
Focus for afamelanotide program - EPP
In early 2010, following feedback from the European Medicines Agency (EMA), Clinuvel announced its program would focus resources on programs for EPP, actinic keratosis (AK) and squamous cell carcinoma in organ transplant recipients (OTRs) and polymorphous light eruption (PLE). Subsequent advances in the treatment of vitiligo led to the commencement of a clinical program for this pigmentary disorder in 2011.
Clinuvel announced that the EMA’s Committee for Human Medicinal Products (CHMP) considered Clinuvel’s existing preclinical package, accompanied by ongoing studies, adequate to support MAA for EPP. The CHMP further acknowledged that SCENESSE® could become the first line treatment for EPP and agreed that no other medicinal products are available for treating EPP (Commission Regulation EC 847/2000).