{"id":31906,"date":"2013-02-04T03:25:12","date_gmt":"2013-02-04T08:25:12","guid":{"rendered":"http:\/\/asweetlife.org\/?post_type=news&p=31906"},"modified":"2015-12-30T02:07:36","modified_gmt":"2015-12-30T07:07:36","slug":"lyxumia-sanofis-type-2-diabetes-treatment-approved-in-eu","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=31906","title":{"rendered":"Lyxumia, Sanofi’s Type 2 Diabetes Treatment, Approved in EU"},"content":{"rendered":"
\"\"<\/a>The European Commission has granted \u00a0Marketing Authorisation in Europe for Sanofi’s new type 2 diabetes treatment, Lyxumia (lixisenatide).<\/div>\n
Lyxumia is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of patients with type 2 diabetes mellitus. \u00a0GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells.<\/p>\n

The European \u00a0Commission decision to grant \u00a0Marketing Authorisation in Europe for Lyxumia is based on results from the GetGoal clinical program, which \u00a0enabled Lyxumia to be the first once-daily GLP-1 receptor agonist \u00a0with a predominantly prandial glucose lowering effect \u00a0to be indicated for use on top of basal insulin and in combination with oral anti-diabetic medications. The clinical program showed that Lyxumia demonstrated significant HbA1c reductions, a pronounced post-prandial glucose lowering effect and a beneficial effect on body weight in adult patients with type 2 diabetes. GetGoal results also showed that Lyxumia had a favorable safety\u00a0and tolerability profile in most patients, with \u00a0mild and transient nausea and vomiting, the most common adverse events observed in the GLP-1 receptor agonist class, and \u00a0a limited risk of hypoglycemia. The international GetGoal program included 11 clinical trials involving more than 5,000 patients with type 2 diabetes, with a large number of patients studied to evaluate a GLP-1 receptor agonist in combination with basal insulin \u00a0(706 patients treated with Lyxumia in three trials).<\/p>\n

Lyxumia was in-licensed from Zealand Pharma A\/S.<\/p>\n

Marketing Authorisation in Europe \u00a0for Lyxumia is applicable to the 27 Member States of the European Union, as well as Iceland, Lichtenstein and Norway, and follows the 15 November 2012 positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency. Applications \u00a0for regulatory approval \u00a0were also submitted \u00a0in several other countries around the world and are being reviewed.<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

The European Commission has granted Marketing Authorisation in Europe for Sanofi’s new type 2 diabetes treatment, Lyxumia (lixisenatide).
\nLyxumia is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of patients with type 2 diabetes mellitus. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. <\/p>\n","protected":false},"author":131,"featured_media":31907,"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":[1072],"yoast_head":"\nLyxumia, Sanofi's Type 2 Diabetes Treatment, Approved in EU<\/title>\n<meta name=\"description\" content=\"The European Commission has granted Marketing Authorisation in Europe for Sanofi's new type 2 diabetes treatment, Lyxumia (lixisenatide).\" \/>\n<meta name=\"robots\" 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