{"id":44565,"date":"2016-05-26T00:00:00","date_gmt":"2016-05-26T04:00:00","guid":{"rendered":"https:\/\/asweetlife.org\/fda-committee-recommends-approving-sanofis-new-combination-insulin-for-type-2-diabetes\/"},"modified":"2016-09-25T04:34:37","modified_gmt":"2016-09-25T08:34:37","slug":"fda-committee-recommends-approving-sanofis-new-combination-insulin-for-type-2-diabetes","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=44565","title":{"rendered":"FDA\u00a0Committee Recommends Approving Sanofi\u2019s New\u00a0Combination Insulin for Type 2 Diabetes"},"content":{"rendered":"<p class=\"p1\" style=\"text-align: justify;\"><a href=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2016\/05\/Sanofi-Logo-Large.png\" rel=\"mfp\"><img decoding=\"async\" class=\"alignleft wp-image-38923 size-medium lazyload\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2016\/05\/Sanofi-Logo-Large-300x200.png\" alt=\"Sanofi Logo\" width=\"300\" height=\"200\" \/><\/a>The U.S. FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has recommended approval of\u00a0Sanofi&#8217;s New Drug Application (NDA) for the investigational fixed-ratio combination of basal insulin glargine 100 Units\/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes. The 15-member panel \u00a0voted 12 to 2 (1 panelist did not vote due to travel)\u00a0to approve the fixed-ratio combination\u00a0of basal insulin glargine 100 Units\/mL and GLP-1 receptor agonist lixisenatide.<i>\u00a0<\/i><\/p>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\">The NDA submission for the fixed-ratio combination of\u00a0basal insulin glargine 100 Units\/mL and GLP-1 receptor agonist lixisenatide\u00a0is based on data from two Phase 3 studies, which enrolled more than 1,900 adults worldwide to evaluate the efficacy and safety of the fixed-ratio combination\u00a0of basal insulin glargine 100 Units\/mL and GLP-1 receptor agonist lixisenatide\u00a0when used in patient populations insufficiently controlled after oral antidiabetic agents (OADs) and after basal insulin therapy, respectively. Both studies met their primary endpoints. The full results of both studies will be presented in June 2016 at the American Diabetes Association&#8217;s 76<\/span><span class=\"s3\">th<\/span><span class=\"s1\">Scientific Sessions.\u00a0<\/span><span class=\"s1\">\u00a0<\/span><\/p>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\">The NDA submission for lixisenatide is based on results from the GetGoal clinical program, which included 13 clinical trials involving more than 5,000 adults with type 2 diabetes.\u00a0The NDA submission for lixisenatide also includes\u00a0findings from the ELIXA study, a long-term cardiovascular (CV) outcomes study in adults with type 2 diabetes and high CV risk (i.e., patients who have recently experienced a spontaneous acute coronary syndrome event).<\/span><span class=\"s1\">\u00a0<\/span><\/p>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\">Lixisenatide and the fixed-ratio combination of\u00a0basal insulin glargine 100 Units\/mL and GLP-1 receptor agonist lixisenatide\u00a0are undergoing FDA review, with decisions anticipated in July and August 2016, respectively. The proprietary names for both compounds in\u00a0the U.S.\u00a0are under consideration. Lixisenatide is currently approved in more than 60 countries worldwide under the proprietary name Lyxumia<\/span><span class=\"s3\">\u00ae<\/span><span class=\"s1\">. The fixed-ratio combination of\u00a0basal insulin glargine 100 Units\/mL and GLP-1 receptor agonist lixisenatide\u00a0was submitted for regulatory review in the European Union in March 2016 and has not yet been approved for use by any health authority.\u00a0\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>&hellip;<\/p>\n","protected":false},"author":131,"featured_media":44566,"comment_status":"open","ping_status":"open","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":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO 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