CLINUVEL Submits New Drug Application for SCENESSE® in Canada

Health Canada Review Process

CLINUVEL has officially filed a New Drug Submission (NDS) to Health Canada, seeking approval for SCENESSE® (afamelanotide) for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). If approved, SCENESSE® would be the first treatment available for Canadian EPP patients.

Health Canada's Health Products and Food Branch (HPFB) is responsible for reviewing and approving medications for use in Canada. The HPFB assesses the safety, efficacy, and quality of the products in the proposed indication. Following a formal dossier validation period, the HPFB may complete the review of a new drug candidate within 300 days.

Special Access Program

In 2023, CLINUVEL announced that the first Canadian EPP patient had received treatment with SCENESSE® under Canada’s Special Access Program (SAP). The SAP allows individual physicians to facilitate access to treatment for patients who have serious or life-threatening conditions and lack therapeutic alternatives. Patient treatment under the SAP continued without interruption prior to Health Canada’s review of the NDS. All Canadian patients treated under the SAP have received insurance coverage to support their treatment access.

Training and Accreditation

Two Canadian Specialty Centers have been trained and accredited to treat EPP patients with SCENESSE®. Further potential Canadian treatment centres have been identified to enable prompt treatment access pending regulatory and pricing approvals. To date, CLINUVEL has trained and accredited 85 Specialty Centers across North America.

Understanding EPP

EPP is a rare genetic disorder that causes phototoxicity, leading to debilitating reactions and burns following light exposure. CLINUVEL has spent nearly two decades developing SCENESSE® as the first treatment for EPP. The drug, administered as a controlled-release injectable implant every 60 days, stimulates the production of melanin in the skin, protecting skin cells from visible and ultraviolet light (photoprotection) and acting as a strong antioxidant.

Clinical and long-term post-marketing studies of SCENESSE® have shown that it can prevent and reduce the severity of phototoxic reactions, as well as improving patients’ quality of life. The drug has been approved for adults by the European Medicines Agency, US Food and Drug Administration (FDA), and regulatory authorities in Australia and Israel. To date, over 16,000 doses of SCENESSE® have been administered to EPP patients worldwide.