{"id":27814,"date":"2012-06-08T03:48:29","date_gmt":"2012-06-08T07:48:29","guid":{"rendered":"http:\/\/asweetlife.org\/?p=27814"},"modified":"2015-12-29T08:53:10","modified_gmt":"2015-12-29T13:53:10","slug":"fda-extends-review-period-of-novo-nordisks-ultra-long-acting-insulin","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=27814","title":{"rendered":"FDA Extends Review Period of Novo Nordisk’s Ultra-Long-Acting Insulins"},"content":{"rendered":"
\"\"<\/a>The U.S. FDA has informed Novo Nordisk that a three-month extension period was required in\u00a0order to complete its\u00a0regulatory\u00a0review of the new drug applications (NDA) for\u00a0the ultra-long-acting\u00a0insulins degludec and insulin degludec\/insulin aspart for the treatment of type 1\u00a0and type 2 diabetes.<\/div>\n
\n
During the review period the FDA has asked for further data clarification and\u00a0analyses. In response, Novo Nordisk has submitted a substantial amount of\u00a0additional data. Due to the size and timing of these submissions the FDA\u00a0considers them as major amendments to the NDAs. The agency has not\u00a0requested additional clinical trials.\u00a0<\/div>\n
\n
Novo Nordisk submitted the NDAs to the FDA on 29 September\u00a02011, and with\u00a0the extension of the review the action date is now 29 October\u00a02012.\u00a0<\/div>\n<\/div>\n
\u00a0<\/div>\n
\n
Insulin degludec<\/strong>\u00a0is a once-daily, ultra-long-acting basal insulin analogue\u00a0discovered and developed by Novo Nordisk. Insulin degludec has a distinct slow\u00a0absorption which provides a flat and stable action profile. It has\u00a0been studied in a large-scale clinical trial programme, BEGIN\u2122, examining its\u00a0impact on glucose control, hypoglycemia and the possibility to flexibly adjust\u00a0insulin degludec dosing time to suit patient needs.<\/div>\n<\/div>\n
\u00a0<\/div>\n
\n
Insulin degludec\/insulin aspart<\/strong>\u00a0contains the ultra-long-acting basal insulin\u00a0degludec in a formulation with a bolus boost of insulin aspart. Insulin\u00a0degludec\/insulin aspart is the first and only soluble insulin combination of ultra-long-acting insulin degludec and the most prescribed rapid acting insulin,\u00a0NovoRapid\u00a0(NovoLogin the US) providing both fasting and post-prandial\u00a0glucose control.\u00a0<\/div>\n
\u00a0<\/div>\n
Insulin degludec and insulin degludec\/insulin aspart were submitted to the\u00a0European Medicines Agency (EMA) and the US Food and Drug Administration \u00a0(FDA) in September\u00a02011\u00a0for regulatory review. In addition, applications have been submitted for regulatory approval in Japan, Canada, Switzerland and a\u00a0range of other countries.<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

The U.S. FDA has informed Novo Nordisk that a three-month extension period was required in order to complete its regulatory review of the new drug applications (NDA) for the ultra-long-acting insulins degludec and insulin degludec\/insulin aspart…<\/p>\n","protected":false},"author":131,"featured_media":27815,"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":[1441],"tags":[1257],"yoast_head":"\nFDA Extends Review Period of Novo Nordisk's Ultra-Long-Acting Insulins<\/title>\n<meta name=\"description\" content=\"The FDA informed Novo Nordisk that a three-month extension period was required to complete its review of the NDA for the ultra-long-acting insulins degludec and insulin degludec\/insulin aspart\" \/>\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=27814\" \/>\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=27814\",\"url\":\"https:\/\/asweetlife.org\/?p=27814\",\"name\":\"FDA Extends Review Period of Novo Nordisk's Ultra-Long-Acting Insulins\",\"isPartOf\":{\"@id\":\"https:\/\/asweetlife.org\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/asweetlife.org\/?p=27814#primaryimage\"},\"image\":{\"@id\":\"https:\/\/asweetlife.org\/?p=27814#primaryimage\"},\"thumbnailUrl\":\"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/06\/NovoNordiskLogo.png\",\"datePublished\":\"2012-06-08T07:48:29+00:00\",\"dateModified\":\"2015-12-29T13:53:10+00:00\",\"author\":{\"@id\":\"https:\/\/asweetlife.org\/#\/schema\/person\/5de2b093878b82b0ea97917f8fd72585\"},\"description\":\"The FDA informed Novo Nordisk that a three-month extension period was required to complete its review of the NDA for the ultra-long-acting insulins degludec and insulin degludec\/insulin aspart\",\"breadcrumb\":{\"@id\":\"https:\/\/asweetlife.org\/?p=27814#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/asweetlife.org\/?p=27814\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/asweetlife.org\/?p=27814#primaryimage\",\"url\":\"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/06\/NovoNordiskLogo.png\",\"contentUrl\":\"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/06\/NovoNordiskLogo.png\",\"width\":215,\"height\":160,\"caption\":\"Novo Nordisk\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/asweetlife.org\/?p=27814#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/asweetlife.org\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"FDA Extends Review Period of Novo Nordisk’s Ultra-Long-Acting Insulins\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/asweetlife.org\/#website\",\"url\":\"https:\/\/asweetlife.org\/\",\"name\":\"ASweetLife\",\"description\":\"The Diabetes Magazine\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/asweetlife.org\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/asweetlife.org\/#\/schema\/person\/5de2b093878b82b0ea97917f8fd72585\",\"name\":\"ASweetLife Team\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/asweetlife.org\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/ba76b5c6c27d32738b13f9a8a5cfcf02?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/ba76b5c6c27d32738b13f9a8a5cfcf02?s=96&d=mm&r=g\",\"caption\":\"ASweetLife Team\"},\"url\":\"https:\/\/asweetlife.org\/?author=131\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"FDA Extends Review Period of Novo Nordisk's Ultra-Long-Acting Insulins","description":"The FDA informed Novo Nordisk that a three-month extension period was required to complete its review of the NDA for the ultra-long-acting insulins degludec and insulin degludec\/insulin aspart","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/asweetlife.org\/?p=27814","twitter_misc":{"Written by":"ASweetLife Team","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/asweetlife.org\/?p=27814","url":"https:\/\/asweetlife.org\/?p=27814","name":"FDA Extends Review Period of Novo Nordisk's Ultra-Long-Acting Insulins","isPartOf":{"@id":"https:\/\/asweetlife.org\/#website"},"primaryImageOfPage":{"@id":"https:\/\/asweetlife.org\/?p=27814#primaryimage"},"image":{"@id":"https:\/\/asweetlife.org\/?p=27814#primaryimage"},"thumbnailUrl":"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/06\/NovoNordiskLogo.png","datePublished":"2012-06-08T07:48:29+00:00","dateModified":"2015-12-29T13:53:10+00:00","author":{"@id":"https:\/\/asweetlife.org\/#\/schema\/person\/5de2b093878b82b0ea97917f8fd72585"},"description":"The FDA informed Novo Nordisk that a three-month extension period was required to complete its review of the NDA for the ultra-long-acting insulins degludec and insulin degludec\/insulin aspart","breadcrumb":{"@id":"https:\/\/asweetlife.org\/?p=27814#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/asweetlife.org\/?p=27814"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/asweetlife.org\/?p=27814#primaryimage","url":"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/06\/NovoNordiskLogo.png","contentUrl":"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/06\/NovoNordiskLogo.png","width":215,"height":160,"caption":"Novo Nordisk"},{"@type":"BreadcrumbList","@id":"https:\/\/asweetlife.org\/?p=27814#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/asweetlife.org\/"},{"@type":"ListItem","position":2,"name":"FDA Extends Review Period of Novo Nordisk’s Ultra-Long-Acting Insulins"}]},{"@type":"WebSite","@id":"https:\/\/asweetlife.org\/#website","url":"https:\/\/asweetlife.org\/","name":"ASweetLife","description":"The Diabetes Magazine","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/asweetlife.org\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/asweetlife.org\/#\/schema\/person\/5de2b093878b82b0ea97917f8fd72585","name":"ASweetLife Team","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/asweetlife.org\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/ba76b5c6c27d32738b13f9a8a5cfcf02?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/ba76b5c6c27d32738b13f9a8a5cfcf02?s=96&d=mm&r=g","caption":"ASweetLife Team"},"url":"https:\/\/asweetlife.org\/?author=131"}]}},"_links":{"self":[{"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/posts\/27814"}],"collection":[{"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/users\/131"}],"replies":[{"embeddable":true,"href":"https:\/\/asweetlife.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=27814"}],"version-history":[{"count":0,"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/posts\/27814\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/media\/27815"}],"wp:attachment":[{"href":"https:\/\/asweetlife.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=27814"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/asweetlife.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=27814"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/asweetlife.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=27814"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}