CLINUVEL Seeks Approval for Groundbreaking EPP Therapy SCENESSE® in Canada

MELBOURNE, Australia, Oct. 1, 2024 – CLINUVEL Pharmaceuticals has submitted a New Drug Submission (NDS) to Health Canada for its innovative photoprotective treatment, SCENESSE® (afamelanotide), aimed at protecting adult patients suffering from erythropoietic protoporphyria (EPP) from phototoxic reactions. Should this submission gain approval, it would mark a significant landmark as the first therapeutic option available for EPP patients in Canada.

Understanding the Health Canada Review Process

Health Canada, through its Health Products and Food Branch (HPFB), evaluates medications for both safety and efficacy before granting approval. The standard review process may complete within approximately 300 days following the formal validation of the submission dossier.

Progress Through the Special Access Program

In 2023, a significant milestone was reached when the first Canadian EPP patient received SCENESSE® through Canada’s Special Access Program (SAP), which provides an avenue for individual physicians to secure treatment for patients with serious conditions lacking alternative therapies. This access continues uninterrupted during the ongoing review process, with patients receiving insurance coverage to support their treatment.

CLINUVEL has also trained two Canadian Specialty Centers to administer SCENESSE®. Further centers have been evaluated for readiness to treat patients pending approval, bringing the total number of trained facilities in North America to 85.

The Impact of EPP

EPP, a rare genetic disorder affecting approximately 1 in 140,000 individuals, results in debilitating reactions and burns when exposed to light, significantly impacting the lives of approximately 280 diagnosed patients in Canada.

Expert Commentary on the Process

Dr. Dennis Wright, Chief Scientific Officer of CLINUVEL, commented, “The Special Access Program has created a vital pathway for Canadian patients, facilitating their access to treatment. A formal authorization would expand availability, allowing more individuals to benefit from SCENESSE®.” He emphasized that the submitted dossier includes vital data related to the FDA’s previous approval along with long-term data gathered from patients globally.

SCENESSE®: A Breakthrough in Photoprotection

SCENESSE® serves a critical role in addressing the needs of EPP patients. Administered as a controlled-release injectable implant every 60 days, it stimulates melanin production, offering robust protection against harmful visible and ultraviolet light and acting as a potent antioxidant. Clinical studies have demonstrated that SCENESSE® not only prevents severe phototoxic reactions but also enhances the overall quality of life for patients.

With approvals already granted in Europe, the United States, Australia, and Israel, SCENESSE® has been administered over 16,000 times to EPP patients worldwide, showcasing its potential impact among those suffering from this rare condition.

Looking Ahead

As CLINUVEL continues to advocate for the health and wellness of EPP patients in Canada, the upcoming review by Health Canada could reshape treatment options and accessibility in the country.

For more information about CLINUVEL's submissions, products, and ongoing research, visit their official website, where insights into their innovative approaches to healthcare solutions can also be found.

Stay tuned for updates as Canada evaluates this pivotal submission that could change the lives of EPP patients forever!