{"id":895,"date":"2014-12-04T13:40:19","date_gmt":"2014-12-04T12:40:19","guid":{"rendered":"http:\/\/www.stargardt.fr\/test\/?page_id=895"},"modified":"2014-12-18T16:27:02","modified_gmt":"2014-12-18T15:27:02","slug":"recherche-et-etudes-en-coursdesignation-medicament-orphelin","status":"publish","type":"page","link":"http:\/\/www.stargardt.fr\/test\/recherche-et-etudes-en-cours\/recherche-et-etudes-en-coursdesignation-medicament-orphelin\/","title":{"rendered":"D\u00e9signation M\u00e9dicament orphelin"},"content":{"rendered":"<h1>\u00ab\u00a0M\u00e9dicament Orphelin\u00a0\u00bb : une d\u00e9signation pour faciliter la recherche<\/h1>\n<p><strong>Parmi les produits en d\u00e9veloppement pour un traitement dans la maladie de Stargardt, certains ont re\u00e7u de l\u2019Agence Europ\u00e9enne de sant\u00e9 (EMA) ou de la Food and Drug Administration\u00a0(FDA, Agence de sant\u00e9 am\u00e9ricaine), la d\u00e9signation \u00ab\u00a0M\u00e9dicament orphelin\u00a0\u00bb.<\/strong><\/p>\n<p>Il s\u2019agit de produits en \u00e9tude (essai de traitement) ayant potentiellement une efficacit\u00e9 sur la maladie rare concern\u00e9e.<\/p>\n<p>Attention, il ne s\u2019agit pas d\u2019un m\u00e9dicament au sens courant du terme mais seulement d\u2019une d\u00e9signation pour des produits \u00e0 l\u2019\u00e9tude pour le traitement de maladie rare. La d\u00e9signation \u00ab\u00a0m\u00e9dicament orphelin\u00a0\u00bb n\u2019est pas une autorisation de mise sur le march\u00e9.<\/p>\n<p>Cette d\u00e9signation est d\u00e9livr\u00e9e par l\u2019EMA et la FDA pour soutenir et prot\u00e9ger les investisseurs qui s\u2019impliquent dans le d\u00e9veloppement de m\u00e9dicaments qui auront par d\u00e9finition un march\u00e9 restreint de patients Car du fait de la raret\u00e9 de la maladie, il y a moins d\u2019investissement pour trouver des traitements.<\/p>\n<p>Aussi, gr\u00e2ce \u00e0 cette d\u00e9signation, les soci\u00e9t\u00e9s impliqu\u00e9es pourront avoir\u00a0:<\/p>\n<ul>\n<li>des avantages pendant le d\u00e9veloppement\u00a0: cr\u00e9dits d\u2019imp\u00f4t, acc\u00e8s privil\u00e9gi\u00e9 aux financements, essais cliniques plus courts et accords r\u00e8glementaires plus facilement accord\u00e9s;<\/li>\n<li>des leviers commerciaux\u00a0: acc\u00e8s rapide au march\u00e9, protection plus longue que pour les m\u00e9dicaments traditionnels apr\u00e8s la mise sur le march\u00e9 (10 ans en Europe, 7 ans aux USA)<\/li>\n<\/ul>\n<p><em>Remarque\u00a0: Condition de raret\u00e9\u00a0<\/em><\/p>\n<p>Une maladie orpheline est une maladie rare qui touche<\/p>\n<ul>\n<li>moins de 5 sur 10 000 personnes en Europe<\/li>\n<li>moins de 200 000 personnes aux Etats-Unis.<\/li>\n<\/ul>\n<div style=\"padding-bottom:20px; padding-top:10px;\" class=\"hupso-share-buttons\"><!-- Hupso Share Buttons - https:\/\/www.hupso.com\/share\/ --><a class=\"hupso_toolbar\" href=\"https:\/\/www.hupso.com\/share\/\"><img src=\"http:\/\/static.hupso.com\/share\/buttons\/lang\/fr\/share.png\" rel=\"PrettyPhoto[895]\" style=\"border:0px; padding-top: 5px; float:left;\" alt=\"Share Button\"\/><\/a><script type=\"text\/javascript\">var hupso_services_t=new Array(\"Twitter\",\"Facebook\",\"Google Plus\");var hupso_background_t=\"#EAF4FF\";var hupso_border_t=\"#66CCFF\";var hupso_toolbar_size_t=\"big\";var hupso_image_folder_url = \"\";var hupso_url_t=\"\";var hupso_title_t=\"D%C3%A9signation%20M%C3%A9dicament%20orphelin%20\";<\/script><script type=\"text\/javascript\" src=\"http:\/\/static.hupso.com\/share\/js\/share_toolbar.js\"><\/script><!-- Hupso Share Buttons --><\/div>","protected":false},"excerpt":{"rendered":"<p>\u00ab\u00a0M\u00e9dicament Orphelin\u00a0\u00bb : une d\u00e9signation pour faciliter la recherche Parmi les produits en d\u00e9veloppement pour un traitement dans la maladie de Stargardt, certains ont re\u00e7u de l\u2019Agence Europ\u00e9enne de sant\u00e9 (EMA) ou de la Food and Drug Administration\u00a0(FDA, Agence de sant\u00e9 am\u00e9ricaine), la d\u00e9signation \u00ab\u00a0M\u00e9dicament orphelin\u00a0\u00bb. Il s\u2019agit de produits en \u00e9tude (essai de traitement)&#8230;<\/p>\n<div style=\"padding-bottom:20px; padding-top:10px;\" class=\"hupso-share-buttons\"><!-- Hupso Share Buttons - https:\/\/www.hupso.com\/share\/ --><a class=\"hupso_toolbar\" href=\"https:\/\/www.hupso.com\/share\/\"><img src=\"http:\/\/static.hupso.com\/share\/buttons\/lang\/fr\/share.png\" style=\"border:0px; padding-top: 5px; float:left;\" alt=\"Share Button\"\/><\/a><script type=\"text\/javascript\">var hupso_services_t=new Array(\"Twitter\",\"Facebook\",\"Google Plus\");var hupso_background_t=\"#EAF4FF\";var hupso_border_t=\"#66CCFF\";var hupso_toolbar_size_t=\"big\";var hupso_image_folder_url = \"\";var hupso_url_t=\"\";var hupso_title_t=\"D%C3%A9signation%20M%C3%A9dicament%20orphelin%20\";<\/script><script type=\"text\/javascript\" src=\"http:\/\/static.hupso.com\/share\/js\/share_toolbar.js\"><\/script><!-- Hupso Share Buttons --><\/div>","protected":false},"author":4,"featured_media":0,"parent":305,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v19.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>D\u00e9signation M\u00e9dicament orphelin  - Nouveau site test<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.stargardt.fr\/test\/recherche-et-etudes-en-cours\/recherche-et-etudes-en-coursdesignation-medicament-orphelin\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"D\u00e9signation M\u00e9dicament orphelin  - Nouveau site test\" \/>\n<meta property=\"og:description\" content=\"\u00ab\u00a0M\u00e9dicament Orphelin\u00a0\u00bb : une d\u00e9signation pour faciliter la recherche Parmi les produits en d\u00e9veloppement pour un traitement dans la maladie de Stargardt, certains ont re\u00e7u de l\u2019Agence Europ\u00e9enne de sant\u00e9 (EMA) ou de la Food and Drug Administration\u00a0(FDA, Agence de sant\u00e9 am\u00e9ricaine), la d\u00e9signation \u00ab\u00a0M\u00e9dicament orphelin\u00a0\u00bb. 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