{"id":31165,"date":"2012-11-09T06:05:50","date_gmt":"2012-11-09T11:05:50","guid":{"rendered":"http:\/\/asweetlife.org\/?post_type=news&p=31165"},"modified":"2015-12-29T08:53:08","modified_gmt":"2015-12-29T13:53:08","slug":"degludec-novo-nordisks-new-insulin-on-its-way-to-fda-approval","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=31165","title":{"rendered":"Degludec, Novo Nordisk’s New Insulin, On Its Way To FDA Approval"},"content":{"rendered":"
\"\"<\/a>The\u00a0Endocrinologic and Metabolic Drugs Advisory Committee of the United States Food and\u00a0Drug Administration (FDA) completed its meeting regarding the New Drug\u00a0Applications (NDA) for Novo Nordisk’s insulin degludec<\/a> (to be marketed under the name Tresiba) and insulin degludec\/insulin aspart.<\/div>\n
\n
\u00a0<\/div>\n
At the meeting, the Advisory Committee was asked to discuss the data contained in the\u00a0NDAs and subsequent submissions regarding the benefits associated with a lower risk of\u00a0hypoglycemia and the cardiovascular risk profiles of the two products.<\/div>\n
\u00a0<\/div>\n
The FDA asked the panel members to vote on whether a cardiovascular outcomes trial\u00a0should be conducted and whether sufficient safety and efficacy data had been provided to\u00a0support marketing of insulin degludec and insulin degludec\/insulin aspart.<\/div>\n
\u00a0<\/div>\n
The committee unanimously recommended that a cardiovascular outcomes trial should\u00a0be conducted and voted eight to four in favor of approving the products with a post-approval outcomes trial commitment.<\/div>\n
\u00a0<\/div>\n
The positive vote from the Advisory Committee marks an important step towards\u00a0making the two therapies available to patients with\u00a0diabetes in the U.S.\u00a0<\/div>\n
\u00a0<\/div>\n
The FDA has not informed Novo Nordisk of when it expects to complete its review of the\u00a0NDAs.<\/div>\n<\/div>\n
\u00a0<\/div>\n
\n
Insulin degludec\u00a0<\/strong>is a once-daily new-generation basal insulin analogue, with an ultralong duration of action, discovered and developed by Novo Nordisk. It has\u00a0a distinct slow absorption which provides a flat and stable action profile. Insulin degludec\u00a0has been studied in a large-scale clinical trial program, BEGIN\u2122, examining its impact\u00a0on glucose control, hypoglycemia and the possibility to flexibly adjust insulin degludec\u00a0dosing time to suit patient needs.\u00a0<\/div>\n
\u00a0<\/div>\n
Insulin degludec\/insulin aspart<\/strong>\u00a0contains the new-generation basal insulin degludec in\u00a0a formulation with a bolus boost of insulin aspart. Insulin degludec\/insulin aspart is the\u00a0first and only soluble insulin combination of insulin degludec and the most prescribed\u00a0rapid-acting insulin, NovoRapid\u00a0(NovoLog\u00a0in the U.S.), providing both fasting and postprandial glucose control.\u00a0<\/div>\n
\u00a0<\/div>\n
Insulin degludec and insulin degludec\/insulin aspart were submitted to the European\u00a0Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) in September\u00a02011\u00a0for regulatory review. In addition, applications have been submitted for regulatory\u00a0approval in Japan, Canada, Switzerland and a range of other countries. Insulin degludec\u00a0was approved in Japan<\/a> in September\u00a02012, and in October\u00a02012\u00a0insulin degludec and\u00a0insulin degludec\/insulin aspart\u00a0received positive CHMP opinions in Europe.<\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

The Endocrinologic and Metabolic Drugs Advisory Committee of the United States Food and Drug Administration (FDA) completed its meeting regarding the New Drug Applications (NDA) for Novo Nordisk’s insulin degludec (to be marketed under the name Tresiba) and insulin degludec\/insulin aspart.<\/p>\n","protected":false},"author":131,"featured_media":31166,"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":[135,1257],"yoast_head":"\nDegludec, Novo Nordisk's New Insulin, On Its Way To FDA Approval<\/title>\n<meta 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