• European label allows one implant every two months, removing recommended maximum dose
• Over 15 years of clinical trial data and Real World Evidence reviewed
• CHMP determine no change in positive benefit-risk profile from uninterrupted dosing

The European Medicines Agency (EMA) has agreed to amend the label for CLINUVEL's photoprotective drug SCENESSE (afamelanotide), enabling adult erythropoietic protoporphyria (EPP) patients to receive treatment every two months. The label removes a recommended maximum annual dose of four implants per year and harmonises treatment posology in Europe with the USA, where many patients receive year-round therapy. The EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the benefit-risk profile of year-round SCENESSE treatment following extensive engagement with CLINUVEL's team. The Committee evaluated data from two Phase III studies (CUV039 and CUV029) and Real World Evidence captured from over 15 years of SCENESSE use under compassionate, special access and commercial programs. The data package included a review of the safety and effectiveness profile of SCENESSE in the European patients who have received four or more implants in any one calendar year. Recognising the clinical need for EPP patients to receive year-round treatment, the CHMP concluded that there were no significant safety concerns with the ongoing administration of SCENESSE every two months. This variation can now be implemented immediately. CLINUVEL has committed to maintaining its obligations under a strict risk management plan for SCENESSE in Europe, including continuing to collect safety and effectiveness outcomes data in EPP patients through the European EPP Disease Registry.