Marketing Authorisation Decision Expected Q4 2025
CLINUVEL Pharmaceuticals has announced that Health Canada has validated its New Drug Submission (NDS) for SCENESSE® (afamelanotide). The therapy is designed to prevent phototoxicity in adult patients with erythropoietic protoporphyria (EPP). This marks an important milestone, with a decision on Canadian marketing authorization anticipated in Q4 2025.
Fast-Track Validation Process
Health Canada’s Health Products and Food Branch (HPFB) has accepted the SCENESSE® dossier for review, completing the validation phase in under 55 days—an expedited timeline demonstrating the robustness of CLINUVEL’s regulatory submission.
The evaluation will proceed under HPFB’s 300-day review target, during which interactions between CLINUVEL and Health Canada are expected to address questions on the drug’s safety, efficacy, and quality.
“This swift validation underscores the diligence of our regulatory team and our experience securing approvals in other major markets,” said Dr. Dennis Wright, CLINUVEL’s Chief Scientific Officer.
SCENESSE® in North America
CLINUVEL has made significant progress in North America since receiving FDA approval for SCENESSE® in 2019 and launching the therapy in the United States in 2020. In Canada, SCENESSE® has been available to EPP patients since 2023 through a Special Access Program (SAP), supported by insurance coverage.
- Canadian Market Potential: With an estimated 280 EPP patients in Canada and no approved treatment currently available, SCENESSE® offers hope for wider access and improved quality of life.
- Specialty Centers: CLINUVEL has established a network of 89 trained and accredited Specialty Centers across North America, including four in Canada, to support patient treatment and ensure safe drug administration.
A Milestone in Photomedicine
SCENESSE® is already approved in Europe, the USA, Australia, and Israel as the first systemic photoprotective therapy for EPP, a condition that causes severe sensitivity to sunlight and UV exposure. With Health Canada’s review underway, CLINUVEL continues to expand its global footprint and reinforce its position as a pioneer in photomedicine and melanocortin therapy.
This development aligns with the company’s broader mission to provide innovative treatments for genetic, metabolic, and acute disorders, addressing unmet medical needs worldwide.
About CLINUVEL
CLINUVEL is a global specialty pharmaceutical group focused on developing solutions for genetic and systemic conditions, with a particular emphasis on photoprotection, DNA repair, and repigmentation therapies. Its flagship drug, SCENESSE®, is at the forefront of systemic photoprotective treatments, offering hope for patients with rare and severe conditions like EPP.
Next Steps: CLINUVEL will provide updates throughout Health Canada’s review process as it works toward enabling full market access for SCENESSE® in Canada.
