{"id":44572,"date":"2016-07-28T00:00:00","date_gmt":"2016-07-28T04:00:00","guid":{"rendered":"https:\/\/asweetlife.org\/fda-approves-adlyxin-sanofis-new-type-2-diabetes-drug\/"},"modified":"2016-09-25T04:19:23","modified_gmt":"2016-09-25T08:19:23","slug":"fda-approves-adlyxin-sanofis-new-type-2-diabetes-drug","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=44572","title":{"rendered":"FDA Approves\u00a0Adlyxin,\u00a0Sanofi\u2019s New Type 2 Diabetes Drug\u00a0"},"content":{"rendered":"<p><a href=\"https:\/\/asweetlife.org\/news\/fda-approves-adlyxin-sanofis-new-type-2-diabetes-drug\/attachment\/sanofi-logo-large-2\/\" rel=\"attachment wp-att-39075\"><img decoding=\"async\" class=\"alignleft wp-image-39075 size-medium lazyload\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2016\/07\/Sanofi-Logo-Large-300x200.png\" alt=\"Sanofi Logo \" width=\"300\" height=\"200\" \/><\/a><\/p>\n<p class=\"p1\" style=\"text-align: justify;\">The U.S. FDA approved Sanofi\u2019s new diabetes drug, Adlyxin (lixisenatide), a once-daily injection to improve glycemic control (blood sugar levels) in adults with type 2 diabetes.<\/p>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\">Adlyxin is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug\u2019s safety and effectiveness were evaluated in 10 clinical trials that enrolled 5,400 patients with type 2 diabetes. In these trials, Adlyxin was evaluated both as a standalone therapy and in combination with other FDA-approved diabetic medications, including metformin, sulfonylureas, pioglitazone and basal insulin. Use of Adlyxin improved hemoglobin A1c levels (a measure of blood sugar levels) in these trials.<\/span><\/p>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\">In addition, more than 6,000 patients with type 2 diabetes at risk for atherosclerotic cardiovascular disease were treated with either Adlyxin or a placebo in a cardiovascular outcomes trial. Use of Adlyxin did not increase the risk of cardiovascular adverse events in these patients.<\/span><\/p>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\">Adlyxin should not be used to treat people with type 1 diabetes or patients with increased ketones in their blood or urine (diabetic ketoacidosis).<\/span><\/p>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\">The most common side effects associated with Adlyxin are nausea, vomiting, headache, diarrhea and dizziness. Hypoglycemia in patients treated with both Adlyxin and other antidiabetic drugs such as sulfonylurea and\/or basal insulin is another common side effect. In addition, severe hypersensitivity reactions, including\u00a0<a href=\"https:\/\/www.nlm.nih.gov\/medlineplus\/anaphylaxis.html\"><span class=\"s3\">anaphylaxis<\/span><\/a>, were reported in clinical trials of Adlyxin.<\/span><\/p>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\">The FDA is requiring the following post-marketing studies for Adlyxin:<\/span><\/p>\n<ul class=\"ul1\" style=\"text-align: justify;\">\n<li class=\"li3\"><span class=\"s1\">Clinical studies to evaluate dosing, efficacy and safety in pediatric patients.<\/span><\/li>\n<li class=\"li3\"><span class=\"s1\">A study evaluating the immunogenicity of lixisenatide.<\/span><\/li>\n<\/ul>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\">\u201cThe FDA continues to support the development of new drug therapies for diabetes management,\u201d said Mary Thanh Hai Parks, M.D., deputy director, Office of Drug Evaluation II in the FDA\u2019s Center for Drug Evaluation and Research. \u201cAdlyxin will add to the available treatment options to control blood sugar levels for those with type 2.\u201d<\/span><\/p>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\">Type 2 diabetes affects more than 29 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness and nerve and kidney damage.<\/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":[1443],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v22.9 (Yoast SEO v22.9) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA 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