{"id":32022,"date":"2013-02-19T05:45:04","date_gmt":"2013-02-19T10:45:04","guid":{"rendered":"http:\/\/asweetlife.org\/?post_type=news&p=32022"},"modified":"2015-12-30T02:09:04","modified_gmt":"2015-12-30T07:09:04","slug":"fda-to-review-nda-for-lixisenatide-sanofis-new-type-2-diabetes-therapy","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=32022","title":{"rendered":"FDA to Review NDA for Lixisenatide, Sanofi’s New Type 2 Diabetes Therapy"},"content":{"rendered":"
\"\"<\/a>The FDA has accepted Sanofi’s New Drug\u00a0Application (NDA) for lixisenatide,\u00a0the first once-daily prandial GLP-1 receptor agonist for the\u00a0treatment of adults with type 2 diabetes, for review.\u00a0The acceptance of the lixisenatide NDA filing\u00a0follows the February 1,\u00a02013, European Commission approval of lixisenatide in the European Union.<\/div>\n
\u00a0<\/div>\n
\n
Lixisenatide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of patients\u00a0with type 2 diabetes mellitus. GLP-1 is a naturally-occurring peptide hormone that is released within\u00a0minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells\u00a0and stimulate glucose-dependent insulin secretion by pancreatic beta cells.\u00a0<\/div>\n
\u00a0<\/div>\n
The NDA submission for lixisenatide is based on results from the GetGoal clinical program, which\u00a0showed that lixisenatide demonstrated significant reductions in HbA1c, a pronounced post-prandial\u00a0glucose (PPG)-lowering effect and a beneficial effect on body weight in adult patients with type 2\u00a0diabetes. GetGoal results also showed that lixisenatide had a favorable safety and tolerability profile\u00a0in most patients, with mild and transient nausea and vomiting, the most common adverse events\u00a0<\/div>\n
observed in the GLP-1 receptor agonist class, and a limited risk of hypoglycemia.<\/div>\n
\u00a0<\/div>\n
The international GetGoal program included 11 clinical trials involving more than 5,000 patients with\u00a0type 2 diabetes,\u00a0with a large number of patients studied to evaluate a GLP-1 receptor agonist in\u00a0combination with basal insulin (1,250 patients treated with lixisenatide \u00a0or placebo \u00a0in three trials).<\/div>\n
\u00a0<\/div>\n
The addition of lixisenatide to basal insulin was studied because these medicines target separate\u00a0components of HbA1c, an important measure of blood glucose control. Lixisenatide has a\u00a0pronounced \u00a0PPG-lowering effect, which complements the predominantly fasting plasma glucose\u00a0(FPG)-lowering effect of basal insulin. For patients treated with basal insulin who have controlled\u00a0FPG but who, due to the progression of type 2 diabetes, are no longer able to achieve their HbA1c\u00a0goal, adding lixisenatide, which targets PPG, could be an effective strategy to \u00a0achieve target\u00a0glucose control.<\/div>\n
\u00a0<\/div>\n
Available data from the ongoing ELIXA trial, a cardiovascular outcome (CV) study of lixisenatide in\u00a0patients at high CV risk (i.e. patients who recently experienced an acute coronary event) were also\u00a0submitted, as required by the FDA.<\/div>\n
\u00a0<\/div>\n
Sanofi is preparing to launch lixisenatide in the European Union as of late Q1\u00a02013\u00a0under the\u00a0proprietary name Lyxumia. The proprietary name for lixisenatide in the United States is under\u00a0consideration.<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

The FDA has accepted Sanofi’s New Drug Application (NDA) for lixisenatide, the first once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes, for review. The acceptance of the lixisenatide NDA filing follows the February 1, 2013, European Commission approval of lixisenatide in the European Union.<\/p>\n","protected":false},"author":131,"featured_media":32023,"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":[1443],"tags":[135,1072,1070],"yoast_head":"\nFDA to Review NDA for Lixisenatide, Sanofi's New Type 2 Diabetes Therapy<\/title>\n<meta name=\"description\" content=\"The FDA has accepted Sanofi's New Drug Application (NDA) for lixisenatide, the first once-daily 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