• CLINUVEL's New Drug Submission (NDS) to Health Canada for SCENESSE® has been validated and accepted for review
• Health Canada's review process has a 300-day target to complete evaluation and issue a decision on marketing authorization
• SCENESSE® is already approved and available in the USA, Europe, Australia and Israel

CLINUVEL's New Drug Submission (NDS) to Health Canada, seeking approval for its novel photoprotective therapy SCENESSE® (afamelanotide) for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP), has been validated and accepted for review ahead of Health Canada's target validation window. The SCENESSE® NDS is now subject to review by Health Canada's Health Products and Food Branch (HPFB), which sets a 300-day target to complete its evaluation and issue a decision on marketing authorization. CLINUVEL's Chief Scientific Officer, Dr Dennis Wright, stated that the prompt validation of the NDS in less than the 55-day validation and screening period reflects the diligence of the regulatory team in compiling a comprehensive dossier to meet the demands of the Canadian authorities. The 300-day review process will involve interactions between CLINUVEL and Health Canada over the coming months. CLINUVEL's success in achieving marketing authorizations in Europe, the USA, Australia and Israel places the company in an optimal position to address any questions on safety, efficacy and quality that may arise, with the ultimate goal of facilitating access to SCENESSE® for all EPP patients who demand treatment. SCENESSE® was launched in the USA in 2020 following FDA approval, and since 2023, Canadian patients have received the treatment under a Special Access Program (SAP), with insurance coverage supporting treatment access. A formal marketing authorization from Health Canada is expected to enable wider treatment access in Canada, where an estimated 280 EPP patients reside. To facilitate patient treatment with SCENESSE® across North America, CLINUVEL has established a network of trained and accredited Specialty Centers, with 89 Centers now established, including four in Canada.

The 300-day review process by Health Canada is an active one, with interactions expected between CLINUVEL and Health Canada over the coming months. A formal marketing authorization from Health Canada is expected to enable wider treatment access for SCENESSE® in Canada, where an estimated 280 EPP patients reside.