{"id":15525,"date":"2011-04-15T09:12:16","date_gmt":"2011-04-15T13:12:16","guid":{"rendered":"http:\/\/asweetlife.org\/?p=15525"},"modified":"2015-12-28T07:38:48","modified_gmt":"2015-12-28T12:38:48","slug":"bydureon-receives-positive-opinion-from-the-european-medicines-agency","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=15525","title":{"rendered":"Bydureon Receives Positive Opinion From The European Medicines Agency"},"content":{"rendered":"

\"\"<\/a>Eli Lilly and Company, Amylin Pharmaceuticals and Alkermes announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of Bydureon for injection in the European Union for the treatment of type 2 diabetes in combination with certain oral therapies. This application to the European regulatory authorities is for use of Bydureon,exenatide 2 mg powder and solvent for prolonged release suspension, as a once-weekly dose to improve glycemic control in adults who have not achieved adequate glycemic control on maximally tolerated doses of oral therapies. If approved, Bydureon would be the first once-weekly type 2 diabetes treatment.\u00a0<\/p>\n

The CHMP’s positive opinion is now referred for final action by the European Commission, which has the authority to approve medicines for the European Union. The Commission usually makes a decision on CHMP recommendations within two to three months.<\/p>\n

In the U.S., the New Drug Application for Bydureon (exenatide extended-release for injectable suspension) was submitted to the U.S. Food and Drug Administration (FDA) in 2009. The FDA issued a complete response letter and requested further data in late 2010. The companies plan to submit a response in the second half of 2011.<\/p>\n","protected":false},"excerpt":{"rendered":"

Eli Lilly and Company, Amylin Pharmaceuticals and Alkermes announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of Bydureon for injection in the European Union for the treatment of type 2 diabetes in combination with…<\/p>\n","protected":false},"author":131,"featured_media":29400,"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":"\nBydureon Receives Positive Opinion From 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