CLINUVEL files Canadian New Drug Submission for 厂颁贰狈贰厂厂贰庐 in EPP
CLINUVEL has filed a New Drug Submission (NDS) to Health Canada for 厂颁贰狈贰厂厂贰庐 (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 厂颁贰狈贰厂厂贰庐 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.
厂颁贰狈贰厂厂贰庐 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 厂颁贰狈贰厂厂贰庐 (afamelanotide), chiedendo l'approvazione per la prevenzione della fototossicit脿 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 pu貌 richiedere fino a 300 giorni.
Nel frattempo, i pazienti canadesi continuano a ricevere 厂颁贰狈贰厂厂贰庐 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.
厂颁贰狈贰厂厂贰庐 猫 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 qualit脿 della vita. Il farmaco 猫 gi脿 stato approvato in Europa, negli USA, in Australia e in Israele.
CLINUVEL ha presentado una Solicitud de Nuevo Medicamento (NDS) a Salud Canad谩 para 厂颁贰狈贰厂厂贰庐 (afamelanotide), buscando la aprobaci贸n para la prevenci贸n de la fototoxicidad en pacientes adultos con protoporfiria eritropoietica (EPP). Si se aprueba, ser铆a el primer tratamiento para pacientes canadienses con EPP. El proceso de revisi贸n de Salud Canad谩 puede tardar hasta 300 d铆as.
Mientras tanto, los pacientes canadienses contin煤an recibiendo 厂颁贰狈贰厂厂贰庐 a trav茅s 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 m谩s para la expansi贸n futura. La EPP afecta aproximadamente a 1 de cada 140,000 individuos, con unos 280 pacientes estimados en Canad谩.
厂颁贰狈贰厂厂贰庐 es un implante inyectable de liberaci贸n controlada que se administra cada 60 d铆as, estimulando la producci贸n de melanina para la fotoprotecci贸n. Ha demostrado eficacia en la prevenci贸n y reducci贸n de reacciones fotot贸xicas en pacientes EPP, mejorando su calidad de vida. El medicamento ya ha sido aprobado en Europa, Estados Unidos, Australia e Israel.
CLINUVEL鞚赌 厂颁贰狈贰厂厂贰庐 (afamelanotide)鞐� 雽�頃� 鞁犾暯 鞁犾箔 (NDS)鞚� 旌愲倶雼� 氤搓贝攵�鞐� 鞝滌稖頃橃棳 順堨儔靻岇儩毽秷攴犿槙歃� (EPP) 頇橃瀽鞚� 甏戨弲靹膘潉 鞓堧癌頃橁赴 鞙勴暅 鞀轨澑鞚� 鞖旍箔頄堨姷雼堧嫟. 鞀轨澑鞚� 霅滊嫟氅� 旌愲倶雼� EPP 頇橃瀽毳� 鞙勴暅 觳� 氩堨Ц 旃橂鞝滉皜 霅� 瓴冹瀰雼堧嫟. 旌愲倶雼� 氤搓贝攵�鞚� 瓴�韱� 瓿检爼鞚赌 斓滊寑 300鞚检澊 靻岇殧霅� 靾� 鞛堨姷雼堧嫟.
鞚挫檧 霃欖嫓鞐� 旌愲倶雼� 頇橃瀽霌れ澏� 韸闺硠 鞝戧芳 頂勲攴鸽灗 (SAP)鞚� 韱淀暣 厂颁贰狈贰厂厂贰庐毳� 瓿勳啀 氚涥碃 鞛堨溂氅�, 氤错棙 順滍儩鞚� 旃橂 鞝戧芳鞚� 歆�鞗愴晿瓿� 鞛堨姷雼堧嫟. 霊� 臧滌潣 旌愲倶雼� 鞝勲 靹柬劙臧� EPP 頇橃瀽毳� 旃橂頃橁赴 鞙勴暣 甑愳湣鞚� 氚涭晿鞙茧┌, 頄ロ泟 頇曤寑毳� 鞙勴暣 雿� 毵庫澏� 靹柬劙臧� 頇曥澑霅橃棃鞀惦媹雼�. EPP電� 鞎� 14毵� 氇� 欷� 1氇呾棎瓴� 鞓來枼鞚� 氙胳箻氅�, 旌愲倶雼れ棎電� 鞎� 280氇呾潣 頇橃瀽臧� 於旍爼霅╇媹雼�.
厂颁贰狈贰厂厂贰庐電� 60鞚茧雼� 韴棳霅橂姅 鞝滌柎 氚╈稖 欤检瀰順� 鞚挫嫕氍茧, 甏戨炒順鸽ゼ 鞙勴暣 氅滊澕雼� 靸濎偘鞚� 鞛愱饭頃╇媹雼�. EPP 頇橃瀽鞐愳劀 甏戨弲靹� 氚橃潙鞚� 鞓堧癌頃橁碃 欷勳澊電� 雿� 須臣臧� 鞛堧姅 瓴冹溂搿� 雮橅儉雮溂氅�, 鞚措摛鞚� 靷鹅潣 歆堨潉 頄レ儊鞁滍偟雼堧嫟. 鞚� 鞎诫鞚赌 鞚措 鞙犽熃, 氙戈淡, 順胳＜ 氚� 鞚挫姢霛检棙鞐愳劀 鞀轨澑霅橃棃鞀惦媹雼�.
CLINUVEL a soumis une Demande de Nouvel M茅dicament (NDS) 脿 Sant茅 Canada pour 厂颁贰狈贰厂厂贰庐 (afamelanotide), demandant l'approbation pour la pr茅vention de la phototoxicit茅 chez les patients adultes atteints de protoporphyrie 茅rythropo茂茅tique (EPP). Si elle est approuv茅e, ce sera le premier traitement pour les patients canadiens atteints d'EPP. Le processus d'examen de Sant茅 Canada peut prendre jusqu'脿 300 jours.
En attendant, les patients canadiens continuent de recevoir 厂颁贰狈贰厂厂贰庐 par le biais du Programme d'Acc猫s Sp茅cial (SAP), avec la couverture d'assurance soutien l'acc猫s au traitement. Deux centres sp茅cialis茅s canadiens ont 茅t茅 form茅s pour traiter les patients EPP, et d'autres ont 茅t茅 identifi茅s pour une future expansion. L'EPP touche environ 1 personne sur 140 000, avec environ 280 patients estim茅s au Canada.
厂颁贰狈贰厂厂贰庐 est un implant injectable 脿 lib茅ration contr么l茅e administr茅 tous les 60 jours, stimulant la production de m茅lanine pour la photoprotection. Il a montr茅 son efficacit茅 dans la pr茅vention et la r茅duction des r茅actions phototoxiques chez les patients EPP, am茅liorant ainsi leur qualit茅 de vie. Le m茅dicament a d茅j脿 茅t茅 approuv茅 en Europe, aux 脡tats-Unis, en Australie et en Isra毛l.
CLINUVEL hat einen Neuen Arzneimittelantrag (NDS) bei Health Canada f眉r 厂颁贰狈贰厂厂贰庐 (afamelanotide) eingereicht und beantragt die Genehmigung zur Pr盲vention von Phototoxizit盲t bei Erwachsenen mit erythropoetischer Protoporphyrie (EPP). Bei Genehmigung w盲re es die erste Behandlung f眉r kanadische EPP-Patienten. Der 脺berpr眉fungsprozess bei Health Canada kann bis zu 300 Tage in Anspruch nehmen.
In der Zwischenzeit erhalten kanadische Patienten 厂颁贰狈贰厂厂贰庐 weiterhin 眉ber das Sonderzugangsprogramm (SAP), mit Versicherungsschutz, der den Zugang zur Behandlung unterst眉tzt. Zwei kanadische Spezialzentren wurden geschult, um EPP-Patienten zu behandeln, und weitere wurden f眉r die zuk眉nftige Expansion identifiziert. EPP betrifft etwa 1 von 140.000 Personen, mit gesch盲tzten 280 Patienten in Kanada.
厂颁贰狈贰厂厂贰庐 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 Lebensqualit盲t verbessert wird. Das Medikament wurde bereits in Europa, den USA, Australien und Israel zugelassen.
- CLINUVEL has filed for regulatory approval of 厂颁贰狈贰厂厂贰庐 in Canada, potentially expanding market access
- 厂颁贰狈贰厂厂贰庐 is already available to Canadian patients through the Special Access Program with insurance coverage
- Two Canadian Specialty Centers are trained to administer 厂颁贰狈贰厂厂贰庐, with more identified for future expansion
- 厂颁贰狈贰厂厂贰庐 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庐 (afamelanotide) for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). If approved, SCENESSE庐 would be the first treatment for Canadian EPP patients.
Health Canada review process
Health Canada鈥檚 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鈥檚 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庐 under Canada鈥檚 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鈥檚 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庐. 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
鈥淭he SAP has provided an important bridge for Canadian patients to access treatment and helped us understand the Canadian therapeutic landscape,鈥� CLINUVEL鈥檚 Chief Scientific Officer, Dr Dennis Wright said. 鈥淎 formal authorisation will enable more Canadian patients to receive SCENESSE庐 and is a logical next step.
鈥淭he dossier submitted contains both data which led to the FDA鈥檚 approval, as well as long-term data collected during the follow up of EPP patients worldwide,鈥� Dr Wright concluded.
SCENESSE庐 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庐 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庐 have shown that it can prevent and reduce the severity of phototoxic reactions, as well as improving patients鈥� 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庐 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鈥�857.
Langendonk, J., et al. (2015). Afamelanotide for Erythropoietic Protoporphyria. The New England Journal of Medicine, 373(1), 48鈥�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鈥�160.
About CLINUVEL PHARMACEUTICALS LIMITED
CLINUVEL (ASX: CUV; ADR LEVEL 1: CLVLY; B枚rse 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鈥檚 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鈥檚 lead therapy, SCENESSE庐 (afamelanotide 16mg), is approved for commercial distribution in Europe, the USA, Israel, and Australia as the world鈥檚 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 .
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This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL鈥檚 management. Please see CLINUVEL鈥檚 website for the full Forward-Looking Statements disclaimer.
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贰尘补颈濒:听Australia (Head Office), Level 22, 535 Bourke Street, Melbourne, Victoria, 3000, Australia
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 厂颁贰狈贰厂厂贰庐 (CLVLY)?
How are Canadian EPP patients currently accessing 厂颁贰狈贰厂厂贰庐 (CLVLY)?
How many EPP patients are estimated to be in Canada?
In which countries has 厂颁贰狈贰厂厂贰庐 (CLVLY) already been approved for EPP treatment?
