CLINUVEL files NDS for SCENESSE in EPP with Health Canada

CLINUVEL (ASX:CUV) has filed a New Drug Submission (NDS) to Health Canada for its photoprotective therapy SCENESSE® (afamelanotide) for adult patients with erythropoietic protoporphyria (EPP). The submission aims to seek approval for SCENESSE® as the first treatment for Canadian EPP patients.

Executive Commentary on Canadian New Drug Submission

The SAP has provided an important bridge for Canadian patients to access treatment and helped us understand the Canadian therapeutic landscape. A formal authorisation will enable more Canadian patients to receive SCENESSE® and is a logical next step. The dossier submitted contains both data which led to the FDA's approval, as well as long-term data collected during the follow up of EPP patients worldwide.

Summary of CLINUVEL's NDS for SCENESSE in EPP

CLINUVEL has filed a New Drug Submission (NDS) to Health Canada for its novel photoprotective therapy SCENESSE® (afamelanotide) for adult patients with erythropoietic protoporphyria (EPP). If approved, SCENESSE® would be the first treatment for Canadian EPP patients. The submission is part of the company's efforts to expand the availability of SCENESSE® to EPP patients globally. The ongoing Patient Special Access Program in Canada continues to provide treatment access for EPP patients during Health Canada's review process. CLINUVEL's ambition to secure approval in Canada reflects its commitment to addressing unmet medical needs and improving the quality of life for EPP patients worldwide.