{"id":27604,"date":"2012-05-28T08:11:29","date_gmt":"2012-05-28T12:11:29","guid":{"rendered":"http:\/\/asweetlife.org\/?p=27604"},"modified":"2015-12-30T04:44:41","modified_gmt":"2015-12-30T09:44:41","slug":"diapep277-granted-orphan-drug-designation-by-fda","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=27604","title":{"rendered":"DiaPep277 Granted Orphan Drug Designation by FDA"},"content":{"rendered":"<div style=\"text-align: justify;\"><a href=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/05\/Diapep277-logo.jpg\" rel=\"mfp\"><img decoding=\"async\" class=\"alignleft size-full wp-image-27605 lazyload\" title=\"Diapep277 - logo\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/05\/Diapep277-logo.jpg\" alt=\"\" width=\"250\" height=\"106\" \/><\/a>The U.S. FDA has\u00a0granted Orphan Drug designation for DiaPep277\u00a0for the treatment of type 1 diabetes (T1D) patients with residual beta cell function.\u00a0The designation of Orphan Drug status offers 7 years marketing exclusivity from the time of approval. In addition, this may present other benefits such as tax incentives, reduced user fees, and assistance for the registration process.<\/div>\n<div style=\"text-align: justify;\">DiaPep277\u00a0is currently in Phase III clinical studies. A first study, which was conducted in Europe, South Africa, and Israel, met its primary endpoint based on initial results. A global confirmatory Phase III study is now being conducted in more than 120 medical centers.\u00a0<\/div>\n<div style=\"text-align: justify;\"><sup><strong><br \/><\/strong><\/sup>DiaPep277, a unique peptide of 24 amino acids derived from the sequence of the human heat shock protein 60 (Hsp60),\u00a0<a href=\"https:\/\/asweetlife.org\/a-sweet-life-staff\/featured\/diapep277-slowing-the-progression-of-type-1-diabetes\/23574\/\">was invented by Prof Irun Cohen and his team<\/a>\u00a0at the Weizmann Institute of Science in Israel. The peptide acts by modulating the immune system, thus preventing the destruction of pancreatic cells that secrete insulin and preserving their natural function. Treatment of type 1 diabetes patients with DiaPep277\u00a0may have several medical benefits including slowing the deterioration of the disease, improved metabolic control, reduction of daily insulin dose requirements, and reduction of diabetic complications.<\/div>\n<div style=\"text-align: justify;\">\u00a0<\/div>\n<div style=\"text-align: justify;\">Diapep277 was developed by\u00a0Andromeda Biotech. In June\u00a02010\u00a0Teva Pharmaceutical decided to exercise its option to invest in Andromeda Biotech receiving\u00a0worldwide\u00a0exclusive\u00a0marketing rights to\u00a0DiaPep277.<\/div>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. FDA has granted Orphan Drug designation for DiaPep277 for the treatment of type 1 diabetes (T1D) patients with residual beta cell function. The designation of Orphan Drug status offers 7 years marketing exclusivity from the time of approval&#8230;.<\/p>\n","protected":false},"author":131,"featured_media":27605,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1446,1445],"tags":[535],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v22.9 (Yoast SEO v22.9) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>DiaPep277 Granted Orphan Drug Designation by FDA<\/title>\n<meta name=\"description\" content=\"The U.S. FDA has granted Orphan Drug designation for DiaPep277 for the treatment of type 1 diabetes patients with residual beta cell function\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/asweetlife.org\/?p=27604\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"ASweetLife Team\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/asweetlife.org\/?p=27604\",\"url\":\"https:\/\/asweetlife.org\/?p=27604\",\"name\":\"DiaPep277 Granted Orphan Drug Designation by FDA\",\"isPartOf\":{\"@id\":\"https:\/\/asweetlife.org\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/asweetlife.org\/?p=27604#primaryimage\"},\"image\":{\"@id\":\"https:\/\/asweetlife.org\/?p=27604#primaryimage\"},\"thumbnailUrl\":\"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/05\/Diapep277-logo.jpg\",\"datePublished\":\"2012-05-28T12:11:29+00:00\",\"dateModified\":\"2015-12-30T09:44:41+00:00\",\"author\":{\"@id\":\"https:\/\/asweetlife.org\/#\/schema\/person\/5de2b093878b82b0ea97917f8fd72585\"},\"description\":\"The U.S. FDA has granted Orphan Drug designation for DiaPep277 for the treatment of type 1 diabetes patients with residual beta cell function\",\"breadcrumb\":{\"@id\":\"https:\/\/asweetlife.org\/?p=27604#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/asweetlife.org\/?p=27604\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/asweetlife.org\/?p=27604#primaryimage\",\"url\":\"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/05\/Diapep277-logo.jpg\",\"contentUrl\":\"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/05\/Diapep277-logo.jpg\",\"width\":250,\"height\":106,\"caption\":\"Diapep277 - 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