{"id":895,"date":"2014-12-04T13:40:19","date_gmt":"2014-12-04T12:40:19","guid":{"rendered":"http:\/\/www.stargardt.fr\/en\/?page_id=895"},"modified":"2015-04-09T17:21:46","modified_gmt":"2015-04-09T16:21:46","slug":"orphan-drug","status":"publish","type":"page","link":"https:\/\/www.stargardt.fr\/en\/current-research-and-trials\/orphan-drug\/","title":{"rendered":"\u201cOrphan Drug\u201d designation"},"content":{"rendered":"<h1><strong>\u201cOrphan Drug\u201d: a designation to ease research <\/strong><\/h1>\n<p><strong>Several products in development for the treatment of Stargardt disease have received the \u201cOrphan Drug\u201d designation from the European Medicines Agency (EMA) or from the Food and Drug Administration (FDA, American Healthy Agency). <\/strong><\/p>\n<p>These are products being studied (treatment trials) which have potential efficacy against the rare disease concerned.<\/p>\n<p><span style=\"text-decoration: underline;\">Warning:<\/span> It is not a medical drug in the usual sense, but it is a designation for products being studied for the treatment of a rare disease. The \u201corphan drug\u201d designation is not a marketing authorisation.<\/p>\n<p>The designation is given by the EMA and the FDA to support and protect investors who involve themselves in the development of medical drugs which will have a limited market of patients by definition: due to the rarity of the disease, there is less investment for treatments.<\/p>\n<p>Thanks to this designation, companies involved will be able to have:<\/p>\n<ul>\n<li>Advantages during development: tax credits, privileged access to funding, shorter clinical trials and more easily granted regulatory agreements.<\/li>\n<li>Commercial leverage: fast market access, longer protection than traditional medical drugs after their market release (10 years in Europe, 7 years in the USA).<\/li>\n<\/ul>\n<p><em style=\"font-size: 16px; line-height: 1.5;\">NB : Condition of rarity: a rare disease \u00a0affects:<\/em><\/p>\n<ul>\n<li><em>Less than 5 out of 10 000 people in Europe<\/em><\/li>\n<li><em>Less than 200\u00a0000 people in the USA <\/em><\/li>\n<\/ul>\n<p><em>\u00a0<\/em><\/p>\n<div style=\"padding-bottom:20px; padding-top:10px;valign:middle;\" class=\"hupso-share-buttons\"><!-- Hupso Share Buttons - https:\/\/www.hupso.com\/share\/ --><a class=\"hupso_toolbar\" href=\"https:\/\/www.hupso.com\/share\/\"><img src=\"https:\/\/static.hupso.com\/share\/buttons\/share-medium.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\",\"Linkedin\",\"Email\");var hupso_background_t=\"#EAF4FF\";var hupso_border_t=\"#66CCFF\";var hupso_toolbar_size_t=\"medium\";var hupso_image_folder_url = \"\";var hupso_url_t=\"\";var hupso_title_t=\"%E2%80%9COrphan%20Drug%E2%80%9D%20designation\";<\/script><script type=\"text\/javascript\" src=\"https:\/\/static.hupso.com\/share\/js\/share_toolbar.js\"><\/script><!-- Hupso Share Buttons --><\/div>","protected":false},"excerpt":{"rendered":"<p>\u201cOrphan Drug\u201d: a designation to ease research Several products in development for the treatment of Stargardt disease have received the \u201cOrphan Drug\u201d designation from the European Medicines Agency (EMA) or from the Food and Drug Administration (FDA, American Healthy Agency). These are products being studied (treatment trials) which have potential efficacy against the rare disease&#8230;<\/p>\n<div style=\"padding-bottom:20px; padding-top:10px;valign:middle;\" class=\"hupso-share-buttons\"><!-- Hupso Share Buttons - https:\/\/www.hupso.com\/share\/ --><a class=\"hupso_toolbar\" href=\"https:\/\/www.hupso.com\/share\/\"><img src=\"https:\/\/static.hupso.com\/share\/buttons\/share-medium.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\",\"Linkedin\",\"Email\");var hupso_background_t=\"#EAF4FF\";var hupso_border_t=\"#66CCFF\";var hupso_toolbar_size_t=\"medium\";var hupso_image_folder_url = \"\";var hupso_url_t=\"\";var hupso_title_t=\"%E2%80%9COrphan%20Drug%E2%80%9D%20designation\";<\/script><script type=\"text\/javascript\" src=\"https:\/\/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>\u201cOrphan Drug\u201d designation<\/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\/en\/current-research-and-trials\/orphan-drug\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u201cOrphan Drug\u201d designation\" \/>\n<meta property=\"og:description\" content=\"\u201cOrphan Drug\u201d: a designation to ease research Several products in development for the treatment of Stargardt disease have received the \u201cOrphan Drug\u201d designation from the European Medicines Agency (EMA) or from the Food and Drug Administration (FDA, American Healthy Agency). 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