CLINUVEL Moves Forward with Drug Submission for EPP Treatment
CLINUVEL Submits New Drug Application for SCENESSE®
CLINUVEL has recently engaged in an important step in the medical field by filing a New Drug Submission (NDS) with Health Canada. This submission focuses on SCENESSE® (afamelanotide), a groundbreaking treatment aimed at preventing phototoxicity in adults diagnosed with erythropoietic protoporphyria (EPP). The approval of SCENESSE® would represent a significant advancement, as it would become the first-ever treatment designated for EPP patients in Canada.
Health Canada’s Evaluation Criteria
Health Canada's Health Products and Food Branch (HPFB) is responsible for reviewing new medications, diligently assessing their safety and efficacy. The department follows a meticulous evaluation process, which includes verifying the quality of the drug and its proposed uses. Post validation of the submitted dossier, the HPFB typically completes the review within 300 days, expediting the potential approval process for this critical medication.
Access through the Canadian Special Access Program
In a notable development, CLINUVEL informed that the first patient diagnosed with EPP in Canada had received SCENESSE® through the Special Access Program (SAP) in the previous year. The SAP is designed to facilitate access to medications for patients afflicted by serious or life-threatening conditions, especially when no alternative treatments are available. Treatment under the SAP has consistently continued as the drug submission for formal review is underway. Furthermore, insurance coverage has been extended to all patients receiving treatment under this program.
In addition, two Specialty Centers across Canada have been trained and accredited specifically to administer SCENESSE® to EPP patients. Others are being identified to ensure that patients have prompt access to their necessary treatments as soon as regulatory and pricing approvals are obtained. CLINUVEL has built a substantial network, having trained and accredited 85 Specialty Centers throughout North America.
Understanding Erythropoietic Protoporphyria
EPP is a rare genetic disorder affecting roughly one in every 140,000 individuals, amounting to about 280 diagnosed patients in Canada. The condition results in severe phototoxicity, leading to painful reactions and burns after exposure to light.
The Role of SCENESSE® in EPP Treatment
CLINUVEL has dedicated nearly 20 years to the development of SCENESSE®, which is now recognized as the first potential treatment specifically for EPP. Administered as a controlled-release implant every 60 days, SCENESSE® stimulates melanin production within the skin, acting as a shield against harmful visible and ultraviolet light. This method not only protects skin cells but also serves as a potent antioxidant.
Clinical trials and long-term post-marketing studies have demonstrated SCENESSE®'s effectiveness in minimizing the occurrence and intensity of phototoxic reactions while significantly enhancing patients’ quality of life. Recognized by renowned regulatory bodies, including the European Medicines Agency and the US Food and Drug Administration, SCENESSE® has successfully treated over 16,000 EPP patients globally.
Insights from Senior Management
CLINUVEL’s Chief Scientific Officer, Dr. Dennis Wright, stated, “The Special Access Program has been an essential route for Canadian patients, granting them access to treatment while enhancing our understanding of the healthcare landscape here.” He further emphasized that securing formal authorization will broaden access, allowing even more patients in Canada to benefit from SCENESSE®.
Dr. Wright emphasized that the dossier submitted contains crucial data paralleling that which led to FDA approval, supplemented by extensive long-term data gathered from EPP patients worldwide.
The Importance of Systemic Photoprotection
Developing SCENESSE® has been a journey of innovation and resilience for CLINUVEL. With a focus on systemic photoprotection and treatment for life-threatening conditions, CLINUVEL continues to make notable strides in the medical arena. The company’s headquarters in Melbourne coordinates its operational reach across Europe, Singapore, and the US, furthering its mission to deliver healthcare solutions for specialized populations.
About CLINUVEL PHARMACEUTICALS LIMITED
CLINUVEL (ASX: CUV; Other OTC: CLVLY; Börse Frankfurt: UR9) specializes in developing therapies for patients experiencing genetic disorders, metabolic conditions, and life-threatening emergencies. Promoting developments in photomedicine and melanocortin peptides, CLINUVEL seeks to address the urgent medical needs of those affected by systemic photoprotection issues among many other health challenges. The company is dedicated to continuous innovation to ensure that patients gain access to life-saving therapies and enhanced quality of life.
Frequently Asked Questions
What is SCENESSE® used for?
SCENESSE® is used for the prevention of phototoxicity in adults with erythropoietic protoporphyria (EPP).
How does SCENESSE® work?
The drug stimulates melanin production in the skin, providing protection against visible and ultraviolet light.
What is the approval process in Canada for new drugs?
Health Canada reviews the safety, efficacy, and quality of new medications, generally completing the evaluation within 300 days after validation of the dossier.
How many EPP patients are there in Canada?
Approximately 280 patients are diagnosed with EPP in Canada, which is a rare genetic disorder.
Is SCENESSE® available in other countries?
Yes, SCENESSE® is approved in several countries, including Europe, the USA, Australia, and Israel.
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