{"id":18419,"date":"2011-07-26T07:05:28","date_gmt":"2011-07-26T11:05:28","guid":{"rendered":"http:\/\/asweetlife.org\/?p=18419"},"modified":"2015-12-30T04:16:54","modified_gmt":"2015-12-30T09:16:54","slug":"takeda-resubmits-new-type-2-diabetes-drugs-for-fda-approval","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=18419","title":{"rendered":"Takeda Resubmits New Type 2 Diabetes Drugs for FDA Approval"},"content":{"rendered":"<p style=\"text-align: justify;\"><strong> <\/strong><br \/> <a href=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2011\/07\/Takeda_Logo.jpg\" rel=\"mfp\"><img decoding=\"async\" class=\"alignleft size-medium wp-image-18421 lazyload\" title=\"Takeda_Logo\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2011\/07\/Takeda_Logo-300x150.jpg\" alt=\"Takeda Logo\" width=\"180\" height=\"90\" data-sizes=\"auto\" data-srcset=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2011\/07\/Takeda_Logo-300x150.jpg 300w, https:\/\/asweetlife.org\/wp-content\/uploads\/2011\/07\/Takeda_Logo.jpg 360w\" sizes=\"(max-width: 180px) 100vw, 180px\" \/><\/a>Takeda has resubmitted two New Drug Applications (NDA) to the U.S. Food and Drug Administration (FDA) for alogliptin and the fixed-dose combination therapy alogliptin\/pioglitazone, which combines alogliptin with pioglitazone, approved in 1999, for the treatment of type 2 diabetes, in a single tablet.<\/p>\n<p style=\"text-align: justify;\">Alogliptin is a selective DPP-4i (dipeptidyl peptidase IV inhibitor) under investigation in the U.S. for the treatment of type 2 diabetes as an adjunct to diet and exercise. DPP-4 inhibitors address insulin deficiency by slowing the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). As a result, an increased amount of active incretins enables the pancreas to secrete insulin, in a glucose-dependent manner, thereby assisting in the management of blood glucose levels.<\/p>\n<p style=\"text-align: justify;\">The NDA resubmissions include interim results from the EXAMINE study, a cardiovascular outcomes trial requested by the FDA to satisfy the criteria outlined in the December 2008 \u201cGuidance for Industry: Diabetes Mellitus \u2014 Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.\u201d The EXAMINE study was designed to comply with the Guidance. This randomized, double-blind, placebo-controlled outcomes study continues to evaluate cardiovascular endpoints following treatment with alogliptin in addition to standard of care, versus standard of care alone, in patients with type 2 diabetes and a recent acute coronary syndrome (ACS). Final study results are expected in 2014.<\/p>\n<div style=\"text-align: justify;\">\n<p>The FDA will review the NDA resubmissions within the next six months.<\/p>\n<p>An NDA for alogliptin was approved in April 2010 by the Japanese Ministry of Health, Labour, and Welfare for the treatment of type 2 diabetes.<\/p>\n<\/div>\n<p style=\"text-align: justify;\">Pioglitazone, marketed as Actos in the U.S., may be associated with an increased risk of bladder cancer.\u00a0 In June the FDA <a href=\"http:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm259150.htm\" target=\"_blank\">announced<\/a> it would require this information to be added to the Warnings and Precautions label of medicines containing pioglitazone.<\/p>\n<p style=\"text-align: justify;\">\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Takeda has resubmitted two New Drug Applications (NDA) to the U.S. Food and Drug Administration (FDA) for alogliptin and the fixed-dose combination therapy alogliptin\/pioglitazone, which combines alogliptin with pioglitazone, approved in 1999, for the treatment of type 2 diabetes, in a single tablet&#8230;<\/p>\n","protected":false},"author":131,"featured_media":18421,"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":[1125],"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>Takeda Resubmits New Type 2 Diabetes Drugs for FDA Approval<\/title>\n<meta name=\"description\" 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