{"id":50357,"date":"2019-03-24T11:29:59","date_gmt":"2019-03-24T15:29:59","guid":{"rendered":"https:\/\/asweetlife.org\/?p=50357"},"modified":"2019-04-10T10:17:48","modified_gmt":"2019-04-10T14:17:48","slug":"fda-rejects-sanofi-lexicon-oral-medication-for-type-1-diabetes","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=50357","title":{"rendered":"FDA Rejects Sanofi-Lexicon Oral Medication for Type 1 Diabetes"},"content":{"rendered":"<p>The FDA has denied approval of Sanofi and Lexicon&#8217;s drug, sotagliflozin, as an add-on to insulin therapy in the treatment of Type 1 diabetes. This decision comes just a few months after an FDA advisory panel failed to reach a consensus over whether the drug&#8217;s benefits outweigh its risks.<\/p>\n<p>Sotagliflozin, works by inhibiting the proteins SGLT1 and SGLT2 to help regulate blood glucose levels and reduce the risk of weight gain. In other words, the drug\u00a0i<a href=\"https:\/\/asweetlife.org\/using-type-2-diabetes-medication-to-treat-type-1-diabetes\/\">nhibits the kidneys\u2019 reabsorption of glucose<\/a>. In a healthy adult, almost 200 grams of glucose go through the kidneys every day \u2013 and it all is reabsorbed. In diabetes, with the higher blood glucose levels the transporter proteins that do this are even more active, so that more glucose can be reabsorbed. Sotagliflozin blocks much of this activity, and people with type 2 diabetes taking it\u00a0tend to lose weight (the increased urine glucose could account for a 200 calorie per day energy deficit) and have lower blood pressure, as well as having a substantial reduction in blood glucose levels. However, in people with Type 1 diabetes (or Type 2&#8217;s with low insulin production), the drug has been linked to the potentially life threatening condition of <a href=\"https:\/\/asweetlife.org\/do-sglt2-inhibitors-like-invokana-cause-ketoacidosis\/\">diabetic ketoacidosis<\/a> (DKA).<\/p>\n<p>According to endocrinologist, <a href=\"https:\/\/asweetlife.org\/its-time-to-change-how-we-treat-diabetes-an-interview-with-dr-mariela-glandt\/\">Dr. Mariela Glandt<\/a>, while sotagliflozin and other SGLT1 and SGLT2 inhibitors can improve glycemic control, the risk of DKA is significant. &#8220;Therefore, the FDA&#8217;s decision doesn&#8217;t surprise me,&#8221; she said. &#8220;Each patient needs to be carefully evaluated before a deciding whether to treat with this class of drugs.&#8221;<\/p>\n<p>On Friday, <a href=\"https:\/\/www.fiercepharma.com\/pharma\/fda-rejects-sanofi-s-type-1-diabetes-hopeful-zynquista\">FiercePharma<\/a> reported that &#8220;Lexicon shares plummeted by 40% as the news [of the FDA&#8217;s denial] broke\u00a0but bounced back a little to be down 24% at 3:30 p.m.&#8221;\u00a0<\/p>\n<p lang=\"EN-US\" xml:lang=\"EN-US\">FiercePharma also reported that &#8220;the FDA\u2019s Friday\u00a0decision marks\u00a0a setback for Sanofi, as the company could badly use the revenue from a new launch. The company was one of a few top\u00a0drugmakers\u00a0to post a sales decline last year. Jefferies analysts had predicted that the drug would generate peak annual sales of $1 billion.\u00a0Sanofi&#8217;s shares were down about 2.5% on Friday afternoon.&#8221;<\/p>\n<div>\u00a0<\/div>\n","protected":false},"excerpt":{"rendered":"<p>&hellip;<\/p>\n","protected":false},"author":2,"featured_media":42177,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"image","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":[1442],"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 Rejects Sanofi-Lexicon Oral Medication for Type 1 Diabetes<\/title>\n<meta name=\"description\" content=\"The FDA has denied approval of Sanofi and Lexicon&#039;s drug, sotagliflozin, as an add-on to insulin therapy in the treatment of Type 1 diabetes. This decision comes just a few months after an FDA advisory panel failed to reach a consensus over whether the drug&#039;s benefits outweigh its risks.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/asweetlife.org\/?p=50357\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Michael Aviad\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/asweetlife.org\/?p=50357\",\"url\":\"https:\/\/asweetlife.org\/?p=50357\",\"name\":\"FDA Rejects Sanofi-Lexicon Oral Medication for Type 1 Diabetes\",\"isPartOf\":{\"@id\":\"https:\/\/asweetlife.org\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/asweetlife.org\/?p=50357#primaryimage\"},\"image\":{\"@id\":\"https:\/\/asweetlife.org\/?p=50357#primaryimage\"},\"thumbnailUrl\":\"https:\/\/asweetlife.org\/wp-content\/uploads\/2014\/12\/iStock_whitepills-scaled.jpg\",\"datePublished\":\"2019-03-24T15:29:59+00:00\",\"dateModified\":\"2019-04-10T14:17:48+00:00\",\"author\":{\"@id\":\"https:\/\/asweetlife.org\/#\/schema\/person\/9f5612f866b93b894ab1ede7211e94c4\"},\"description\":\"The FDA has denied approval of Sanofi and Lexicon's drug, sotagliflozin, as an add-on to insulin therapy in the treatment of Type 1 diabetes. 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