{"id":24153,"date":"2012-01-28T04:12:03","date_gmt":"2012-01-28T09:12:03","guid":{"rendered":"http:\/\/asweetlife.org\/?p=24153"},"modified":"2015-12-30T04:32:27","modified_gmt":"2015-12-30T09:32:27","slug":"fda-approves-type-2-diabetes-drug-bydureon","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=24153","title":{"rendered":"FDA Approves Type 2 Diabetes Drug Bydureon"},"content":{"rendered":"<div>\n<div style=\"text-align: justify;\"><a href=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/01\/Bydureon-Vial.jpg\" rel=\"mfp\"><img decoding=\"async\" class=\"alignleft size-full wp-image-24156 lazyload\" title=\"Bydureon-Vial\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/01\/Bydureon-Vial.jpg\" alt=\"\" width=\"200\" height=\"271\" \/><\/a>Amylin Pharmaceuticals, Inc. and Alkermes plc\u00a0received\u00a0FDA approval for\u00a0Bydureon, a next generation\u00a0once-weekly\u00a0<wbr>treatment for type 2 diabetes. The drug which\u00a0received\u00a0<a href=\"https:\/\/asweetlife.org\/a-sweet-life-staff\/in-the-news\/type-2-in-the-news\/lilly-and-amylin-type-2-diabetes-drug-bydureon-approved-for-marketing-in-europe\/17367\/\" target=\"_blank\">EU approval<\/a>\u00a0in June was turned down by the FDA twice during 2010, requesting further testing be conducted.\u00a0<\/wbr><\/div>\n<\/div>\n<div style=\"text-align: justify;\">\u00a0<\/div>\n<div style=\"text-align: justify;\">Bydureon, which is injected once a week, is due to replace Amylin&#8217;s twice daily Byetta and will compete against Novo Nordisk&#8217;s popular once daily, Victoza.<\/div>\n<div style=\"text-align: justify;\">\u00a0<\/div>\n<div>\n<div style=\"text-align: justify;\">The approval of\u00a0 Bydureon\u00a0was based on safety and efficacy data from the DURATION clinical trial program, in which treatment with\u00a0 Bydureon\u00a0\u00a0resulted in improvements in glycemic control with just one dose per week. The approval was also based on clinical experience with\u00a0 Byetta\u00a0(exenatide) injection, a twice-daily form of exenatide that has been available in the U.S. since June 2005 and is used in nearly 80 countries worldwide.\u00a0 Bydureon\u00a0uses Alkermes&#8217; proprietary technology for long-acting medications to provide a controlled release of exenatide.<\/div>\n<div style=\"text-align: justify;\">\u00a0<\/div>\n<div style=\"text-align: justify;\">Bydureon\u00a0has been approved with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of\u00a0 Bydureon\u00a0outweigh the risk of acute pancreatitis and the potential risk of medullary thyroid carcinoma. As part of the REMS, Amylin has established a communication plan for healthcare professionals to help minimize these risks. In addition, Amylin will fulfill a number of post-marketing requirements to further assess the impact of\u00a0 Bydureon\u00a0on medullary thyroid cancer and cardiovascular disease. More information will be available at<a href=\"http:\/\/www.bydureon.com\/\" target=\"_blank\">www.BYDUREON.com<\/a>.\u00a0<\/div>\n<div style=\"text-align: justify;\">\u00a0<\/div>\n<div style=\"text-align: justify;\">Bydureon\u00a0is provided in a straightforward single-dose tray so that patients can self-administer the once-weekly subcutaneous injection.\u00a0Bydureon\u00a0will be available in pharmacies nationwide in February.<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Amylin Pharmaceuticals, Inc. and Alkermes plc received FDA approval for Bydureon, a next generation once-weekly treatment for type 2 diabetes. The drug which received EU approval in June was turned down by the FDA twice during 2010, requesting further testing be conducted&#8230;<\/p>\n","protected":false},"author":131,"featured_media":29362,"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":[1443],"tags":[671],"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 Type 2 Diabetes Drug, Bydureon<\/title>\n<meta name=\"description\" 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