{"id":36542,"date":"2014-08-19T10:30:59","date_gmt":"2014-08-19T14:30:59","guid":{"rendered":"http:\/\/asweetlife.org\/?post_type=news&#038;p=36542"},"modified":"2015-12-30T05:28:19","modified_gmt":"2015-12-30T10:28:19","slug":"fda-grants-tentative-approval-to-lillys-new-insulin-glargine-injection-basaglar","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=36542","title":{"rendered":"FDA Grants Tentative Approval to Lilly\u2019s New Insulin Glargine Injection Basaglar"},"content":{"rendered":"<p style=\"text-align: justify;\"><a href=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2014\/08\/Lilly-Boehringer-logo.jpg\" rel=\"mfp\"><img decoding=\"async\" class=\"alignleft size-full wp-image-36543 lazyload\" title=\"Lilly - Boehringer - logo\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2014\/08\/Lilly-Boehringer-logo.jpg\" alt=\"\" width=\"206\" height=\"131\" \/><\/a>The U.S. FDA has granted tentative approval for Basaglar (insulin glargine injection). With a tentative approval, the\u00a0FDA\u00a0has determined that Basaglar meets all of the regulatory requirements for approval, but it is subject to an automatic stay of up to 30 months as a result of litigation filed by Sanofi claiming patent infringement. Under the\u00a0Drug Price Competition\u00a0and Patent Term Restoration Act (\u201cHatch Waxman&#8221;), the\u00a0FDA\u00a0cannot give final approval until the end of the 30-month period in mid-2016, unless the court finds in favor of Lilly earlier.<\/p>\n<p style=\"text-align: justify;\">Basaglar is a new basal insulin indicated to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type 1 diabetes. Basaglar is not recommended for the treatment of diabetic ketoacidosis. \u00a0<\/p>\n<p style=\"text-align: justify;\">Basaglar has the same amino acid sequence as the currently marketed insulin glargine product and was tentatively approved for use with KwikPen, a pre-filled dosing device. Basaglar is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin glargine or one of its other ingredients.<\/p>\n<p style=\"text-align: justify;\">The tentative approval is based, in part, on results from Lilly and Boehringer Ingelheim&#8217;s extensive clinical development program for the alliance&#8217;s insulin glargine product. The submission included results from pharmacokinetic and pharmacodynamics studies, as well as Phase III studies in people with type 1 and type 2 diabetes.<\/p>\n<p style=\"text-align: justify;\">The trade name &#8216;Basaglar&#8217; was granted provisional approval by\u00a0FDA\u00a0and will be used in the U.S. market once the product is made available to patients. While &#8216;Abasria<sup>\u00ae<\/sup>&#8216; is an approved name in\u00a0Europe, it&#8217;s not necessarily approved in other regions. Lilly and Boehringer Ingelheim are targeting a global trade name outside of\u00a0the United States\u00a0for the alliance&#8217;s insulin glargine product, which will be announced at a later date.<\/p>\n<p style=\"text-align: justify;\">\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"<p>&hellip;<\/p>\n","protected":false},"author":131,"featured_media":36543,"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":[1441],"tags":[1356],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v22.9 (Yoast SEO v22.9) - 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