CLINUVEL files Canadian New Drug Submission for SCENESSE® in EPP
CLINUVEL has filed a New Drug Submission (NDS) to Health Canada for SCENESSE® (afamelanotide), seeking approval for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). If approved, it would be the first treatment for Canadian EPP patients. The Health Canada review process may take up to 300 days.
Meanwhile, Canadian patients continue to receive SCENESSE® through the Special Access Program (SAP), with insurance coverage supporting treatment access. Two Canadian Specialty Centers have been trained to treat EPP patients, with more identified for future expansion. EPP affects approximately 1:140,000 individuals, with an estimated 280 patients in Canada.
SCENESSE® is a controlled-release injectable implant administered every 60 days, stimulating melanin production for photoprotection. It has shown efficacy in preventing and reducing phototoxic reactions in EPP patients, improving their quality of life. The drug has already been approved in Europe, the USA, Australia, and Israel.
CLINUVEL ha presentato una Nuova Richiesta di Autorizzazione dei Farmaci (NDS) a Salute Canada per SCENESSE® (afamelanotide), chiedendo l'approvazione per la prevenzione della fototossicità in pazienti adulti con protoporfiria eritropoietica (EPP). Se approvato, sarebbe il primo trattamento per i pazienti canadesi affetti da EPP. Il processo di revisione di Salute Canada può richiedere fino a 300 giorni.
Nel frattempo, i pazienti canadesi continuano a ricevere SCENESSE® tramite il Programma di Accesso Speciale (SAP), con copertura assicurativa che supporta l'accesso al trattamento. Due Centri Specializzati canadesi sono stati formati per trattare i pazienti EPP, con ulteriori centri identificati per espansioni future. L'EPP colpisce circa 1 ogni 140.000 individui, con circa 280 pazienti stimati in Canada.
SCENESSE® è un impianto iniettabile a rilascio controllato, somministrato ogni 60 giorni, che stimola la produzione di melanina per la fotoprotezione. Ha dimostrato di essere efficace nella prevenzione e riduzione delle reazioni fototossiche nei pazienti EPP, migliorando la loro qualità della vita. Il farmaco è già stato approvato in Europa, negli USA, in Australia e in Israele.
CLINUVEL ha presentado una Solicitud de Nuevo Medicamento (NDS) a Salud Canadá para SCENESSE® (afamelanotide), buscando la aprobación para la prevención de la fototoxicidad en pacientes adultos con protoporfiria eritropoietica (EPP). Si se aprueba, sería el primer tratamiento para pacientes canadienses con EPP. El proceso de revisión de Salud Canadá puede tardar hasta 300 días.
Mientras tanto, los pacientes canadienses continúan recibiendo SCENESSE® a través del Programa de Acceso Especial (SAP), con la cobertura del seguro que apoya el acceso al tratamiento. Dos Centros Especializados canadienses han sido entrenados para tratar a pacientes con EPP, y se han identificado más para la expansión futura. La EPP afecta aproximadamente a 1 de cada 140,000 individuos, con unos 280 pacientes estimados en Canadá.
SCENESSE® es un implante inyectable de liberación controlada que se administra cada 60 días, estimulando la producción de melanina para la fotoprotección. Ha demostrado eficacia en la prevención y reducción de reacciones fototóxicas en pacientes EPP, mejorando su calidad de vida. El medicamento ya ha sido aprobado en Europa, Estados Unidos, Australia e Israel.
CLINUVEL은 SCENESSE® (afamelanotide)에 대한 신약 신청 (NDS)을 캐나다 보건부에 제출하여 혈색소생리불균형증 (EPP) 환자의 광독성을 예방하기 위한 승인을 요청했습니다. 승인이 된다면 캐나다 EPP 환자를 위한 첫 번째 치료제가 될 것입니다. 캐나다 보건부의 검토 과정은 최대 300일이 소요될 수 있습니다.
이와 동시에 캐나다 환자들은 특별 접근 프로그램 (SAP)을 통해 SCENESSE®를 계속 받고 있으며, 보험 혜택이 치료 접근을 지원하고 있습니다. 두 개의 캐나다 전문 센터가 EPP 환자를 치료하기 위해 교육을 받았으며, 향후 확대를 위해 더 많은 센터가 확인되었습니다. EPP는 약 14만 명 중 1명에게 영향을 미치며, 캐나다에는 약 280명의 환자가 추정됩니다.
SCENESSE®는 60일마다 투여되는 제어 방출 주입형 이식물로, 광보호를 위해 멜라닌 생산을 자극합니다. EPP 환자에서 광독성 반응을 예방하고 줄이는 데 효과가 있는 것으로 나타났으며, 이들의 삶의 질을 향상시킵니다. 이 약물은 이미 유럽, 미국, 호주 및 이스라엘에서 승인되었습니다.
CLINUVEL a soumis une Demande de Nouvel Médicament (NDS) à Santé Canada pour SCENESSE® (afamelanotide), demandant l'approbation pour la prévention de la phototoxicité chez les patients adultes atteints de protoporphyrie érythropoïétique (EPP). Si elle est approuvée, ce sera le premier traitement pour les patients canadiens atteints d'EPP. Le processus d'examen de Santé Canada peut prendre jusqu'à 300 jours.
En attendant, les patients canadiens continuent de recevoir SCENESSE® par le biais du Programme d'Accès Spécial (SAP), avec la couverture d'assurance soutien l'accès au traitement. Deux centres spécialisés canadiens ont été formés pour traiter les patients EPP, et d'autres ont été identifiés pour une future expansion. L'EPP touche environ 1 personne sur 140 000, avec environ 280 patients estimés au Canada.
SCENESSE® est un implant injectable à libération contrôlée administré tous les 60 jours, stimulant la production de mélanine pour la photoprotection. Il a montré son efficacité dans la prévention et la réduction des réactions phototoxiques chez les patients EPP, améliorant ainsi leur qualité de vie. Le médicament a déjà été approuvé en Europe, aux États-Unis, en Australie et en Israël.
CLINUVEL hat einen Neuen Arzneimittelantrag (NDS) bei Health Canada für SCENESSE® (afamelanotide) eingereicht und beantragt die Genehmigung zur Prävention von Phototoxizität bei Erwachsenen mit erythropoetischer Protoporphyrie (EPP). Bei Genehmigung wäre es die erste Behandlung für kanadische EPP-Patienten. Der Überprüfungsprozess bei Health Canada kann bis zu 300 Tage in Anspruch nehmen.
In der Zwischenzeit erhalten kanadische Patienten SCENESSE® weiterhin über das Sonderzugangsprogramm (SAP), mit Versicherungsschutz, der den Zugang zur Behandlung unterstützt. Zwei kanadische Spezialzentren wurden geschult, um EPP-Patienten zu behandeln, und weitere wurden für die zukünftige Expansion identifiziert. EPP betrifft etwa 1 von 140.000 Personen, mit geschätzten 280 Patienten in Kanada.
SCENESSE® ist ein kontrolliertes, injizierbares Implantat, das alle 60 Tage verabreicht wird und die Melaninproduktion zur Photoprotektion anregt. Es hat sich als wirksam erwiesen, um phototoxische Reaktionen bei EPP-Patienten zu verhindern und zu reduzieren, wodurch die Lebensqualität verbessert wird. Das Medikament wurde bereits in Europa, den USA, Australien und Israel zugelassen.
- CLINUVEL has filed for regulatory approval of SCENESSE® in Canada, potentially expanding market access
- SCENESSE® is already available to Canadian patients through the Special Access Program with insurance coverage
- Two Canadian Specialty Centers are trained to administer SCENESSE®, with more identified for future expansion
- SCENESSE® has demonstrated efficacy in preventing and reducing phototoxic reactions in EPP patients
- The drug has been approved in multiple countries, including the USA and Europe
- The Health Canada review process may take up to 300 days, delaying potential market entry
- EPP is a rare condition, affecting only an estimated 280 patients in Canada, limiting the potential market size
Patient Special Access Program continues during Health Canada review
MELBOURNE, Australia, Oct. 01, 2024 (GLOBE NEWSWIRE) -- CLINUVEL has filed a 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). If approved, SCENESSE® would be the first treatment for Canadian EPP patients.
Health Canada review process
Health Canada’s Health Products and Food Branch (HPFB) reviews and approves medications for use in Canada, assessing the safety and efficacy of the products in the proposed indication, as well as the drug’s quality. Following a formal dossier validation period, the HPFB may complete the review of a new drug candidate within 300 days.
Canadian Special Access Program ongoing
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.
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.
EPP affects approximately 1:140,000 individuals, with an estimated 280 EPP patients in Canada.
Commentary
“The SAP has provided an important bridge for Canadian patients to access treatment and helped us understand the Canadian therapeutic landscape,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said. “A formal authorisation will enable more Canadian patients to receive SCENESSE® and is a logical next step.
“The dossier submitted contains both data which led to the FDA’s approval, as well as long-term data collected during the follow up of EPP patients worldwide,” Dr Wright concluded.
SCENESSE® in EPP: systemic photoprotection
EPP is a rare genetic disorder which causes phototoxicity, 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 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.
References
Ceresnie, M. S., et al. (2022). Association of quality of life measures with afamelanotide treatment in patients with erythropoietic protoporphyria and x-linked protoporphyria: A retrospective cohort study. Journal of the American Academy of Dermatology, S0190962222028729.
Elder, G., et al. (2013). The incidence of inherited porphyrias in Europe. Journal of Inherited Metabolic Disease, 36(5), 849–857.
Langendonk, J., et al. (2015). Afamelanotide for Erythropoietic Protoporphyria. The New England Journal of Medicine, 373(1), 48–59.
Wensink, D., Wagenmakers, M. A. E. M., & Langendonk, J. G. (2021). Afamelanotide for prevention of phototoxicity in erythropoietic protoporphyria. Expert Review of Clinical Pharmacology, 14(2), 151–160.
About CLINUVEL PHARMACEUTICALS LIMITED
CLINUVEL (ASX: CUV; ADR LEVEL 1: CLVLY; Börse Frankfurt: UR9) is a global specialty pharmaceutical group focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening, acute disorders, as well as healthcare solutions for specialised populations. As pioneers in photomedicine and the family of melanocortin peptides, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for systemic photoprotection, assisted DNA repair, repigmentation and acute or life-threatening conditions who lack alternatives.
CLINUVEL’s lead therapy, SCENESSE® (afamelanotide 16mg), is approved for commercial distribution in Europe, the USA, Israel, and Australia as the world’s first systemic photoprotective drug for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore, and the USA. For more information, please go to https://www.clinuvel.com.
Authorised for ASX release by the Board of Directors of CLINUVEL PHARMACEUTICALS LTD.
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Mr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTD
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Forward-Looking Statements
This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL’s management. Please see CLINUVEL’s website for the full Forward-Looking Statements disclaimer.
Contact:
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Email: mail@clinuvel.com
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FAQ
What is CLINUVEL seeking approval for with its New Drug Submission to Health Canada?
How long might the Health Canada review process take for SCENESSE® (CLVLY)?
How are Canadian EPP patients currently accessing SCENESSE® (CLVLY)?
How many EPP patients are estimated to be in Canada?
In which countries has SCENESSE® (CLVLY) already been approved for EPP treatment?
