{"id":35475,"date":"2014-03-05T10:32:09","date_gmt":"2014-03-05T15:32:09","guid":{"rendered":"http:\/\/asweetlife.org\/?post_type=news&p=35475"},"modified":"2015-12-28T08:42:10","modified_gmt":"2015-12-28T13:42:10","slug":"fda-issues-complete-response-letter-for-type-2-diabetes-drug-empagliflozin","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=35475","title":{"rendered":"FDA Issues Complete Response Letter for Type 2 Diabetes Drug Empagliflozin"},"content":{"rendered":"
\n

\"\"<\/a>The\u00a0FDA has issued a complete response letter to\u00a0Boehringer Ingelheim and\u00a0Eli Lilly\u00a0\u00a0for the New Drug Application (NDA) of the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin.<\/p>\n<\/div>\n

\n

The complete response letter referenced previously observed\u00a0deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured. The\u00a0FDA\u00a0stated these deficiencies need to be resolved before the approval of the application. The\u00a0FDA\u00a0has not asked Boehringer Ingelheim to complete any new clinical trials to support the approval of the application.<\/p>\n

Empagliflozin is a sodium glucose co-transporter-2 (SGLT2) inhibitor class of compounds, and is being investigated for the reduction of blood glucose levels in adults with type 2 diabetes. The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption by the kidney.<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

The FDA has issued a complete response letter to Boehringer Ingelheim and Eli Lilly for the New Drug Application (NDA) of the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin.
\nThe complete response letter referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured.<\/p>\n","protected":false},"author":131,"featured_media":35476,"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":[1442],"tags":[1548],"yoast_head":"\nFDA Issues Complete Response Letter for Type 2 Diabetes Drug Empagliflozin<\/title>\n<meta name=\"description\" content=\"The FDA issued a complete response letter to Boehringer Ingelheim and Eli Lilly for the NDA of the sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin.\" \/>\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=35475\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"ASweetLife Team\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/asweetlife.org\/?p=35475\",\"url\":\"https:\/\/asweetlife.org\/?p=35475\",\"name\":\"FDA Issues Complete Response Letter for Type 2 Diabetes Drug Empagliflozin\",\"isPartOf\":{\"@id\":\"https:\/\/asweetlife.org\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/asweetlife.org\/?p=35475#primaryimage\"},\"image\":{\"@id\":\"https:\/\/asweetlife.org\/?p=35475#primaryimage\"},\"thumbnailUrl\":\"https:\/\/asweetlife.org\/wp-content\/uploads\/2014\/03\/Lilly-Boehringer-logo.jpg\",\"datePublished\":\"2014-03-05T15:32:09+00:00\",\"dateModified\":\"2015-12-28T13:42:10+00:00\",\"author\":{\"@id\":\"https:\/\/asweetlife.org\/#\/schema\/person\/5de2b093878b82b0ea97917f8fd72585\"},\"description\":\"The FDA issued a complete response letter to Boehringer Ingelheim and Eli Lilly for the NDA of the sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin.\",\"breadcrumb\":{\"@id\":\"https:\/\/asweetlife.org\/?p=35475#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/asweetlife.org\/?p=35475\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/asweetlife.org\/?p=35475#primaryimage\",\"url\":\"https:\/\/asweetlife.org\/wp-content\/uploads\/2014\/03\/Lilly-Boehringer-logo.jpg\",\"contentUrl\":\"https:\/\/asweetlife.org\/wp-content\/uploads\/2014\/03\/Lilly-Boehringer-logo.jpg\",\"width\":206,\"height\":131,\"caption\":\"Lilly - 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