{"id":37660,"date":"2015-02-26T05:55:05","date_gmt":"2015-02-26T10:55:05","guid":{"rendered":"http:\/\/asweetlife.org\/?post_type=news&#038;p=37660"},"modified":"2015-12-30T06:01:07","modified_gmt":"2015-12-30T11:01:07","slug":"fda-approves-toujeo-sanofis-new-long-acting-insulin","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=37660","title":{"rendered":"FDA Approves Toujeo, Sanofi\u2019s New Long Acting Insulin\u00a0"},"content":{"rendered":"<div><\/div>\n<div style=\"text-align: justify;\"><a href=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2015\/02\/sanofi-logo.jpg\" rel=\"mfp\"><img decoding=\"async\" class=\"alignleft size-full wp-image-37661 lazyload\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2015\/02\/sanofi-logo.jpg\" alt=\"sanofi-logo\" width=\"120\" height=\"86\" \/><\/a>The U.S. Food and Drug Administration (FDA) approved Sanofi\u2019s new once daily long acting insulin, Toujeo\u00a0(insulin glargine [rDNA origin] injection, 300 U\/mL) for treatment of adults living with type 1 and type 2 diabetes.<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">\n<div>Toujeo will be available in the Toujeo SoloSTAR, a disposable prefilled pen which contains 450 units of Toujeo and requires one third of the\u00a0injection volume to deliver the same number of insulin units as compared to the Lantus SoloSTAR. The maximum single injection dose of 80 IU meets the needs of the vast majority of patients on basal insulin in the U.S., who require 80 IU or less per day. Toujeo is currently pending marketing authorization with the European Medicines Agency (EMA) and other health authorities around the world.<\/div>\n<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">The approval of Toujeo was based on FDA review\u00a0of results from the EDITION clinical trial program, which was comprised of a series of international Phase III studies evaluating the efficacy and safety of Toujeo in more than 3,500 adults from broad and diverse diabetes populations (type 1 and type 2).\u00a0In the clinical trial program leading to approval, once-daily\u00a0Toujeo was compared to that of once-daily Lantus\u00a0(insulin glargine [rDNA origin] injection, 100 U\/mL)\u00a0in open-label, randomized, active-control, parallel, treat-to-target studies of up to 26 weeks of duration with 6 months safety extension.<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<p style=\"text-align: justify;\">Toujeo\u00a0is expected to be available in the U.S. at the beginning of Q2 2015.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) approved Sanofi\u2019s new once daily long acting insulin, Toujeo (insulin glargine [rDNA origin] injection, 300 U\/mL) for treatment of adults living with type 1 and type 2 diabetes.<br \/>\nToujeo will be available in the Toujeo SoloSTAR, a disposable prefilled pen which contains 450 units of Toujeo and requires one third of the injection volume to deliver the same number of insulin units as compared to the Lantus SoloSTAR. <\/p>\n","protected":false},"author":131,"featured_media":37661,"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":[1351],"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 Approves Toujeo, Sanofi\u2019s New Long Acting Insulin\u00a0<\/title>\n<meta name=\"description\" content=\"The U.S. FDA approved Sanofi\u2019s new once daily long acting insulin, Toujeo for treatment of adults living with 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