{"id":8763,"date":"2016-05-10T07:12:17","date_gmt":"2016-05-10T07:12:17","guid":{"rendered":"http:\/\/revoscience.com\/en\/?p=8763"},"modified":"2016-05-10T07:12:17","modified_gmt":"2016-05-10T07:12:17","slug":"intarcia-preps-fda-filing-for-revolutionary-diabetes-drug","status":"publish","type":"post","link":"https:\/\/www.revoscience.com\/en\/intarcia-preps-fda-filing-for-revolutionary-diabetes-drug\/","title":{"rendered":"Intarcia Preps FDA Filing for Revolutionary Diabetes Drug"},"content":{"rendered":"<p style=\"text-align: justify;\"><span style=\"color: rgb(0, 0, 0);\"><a href=\"http:\/\/revoscience.com\/en\/wp-content\/uploads\/2016\/05\/ddd1605_insulin.jpg\" target=\"_blank\" rel=\"noopener\"><img loading=\"lazy\" decoding=\"async\" class=\"alignright size-medium wp-image-8764\" src=\"http:\/\/revoscience.com\/en\/wp-content\/uploads\/2016\/05\/ddd1605_insulin-300x225.jpg\" alt=\"ddd1605_insulin\" width=\"300\" height=\"225\" title=\"\" srcset=\"https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/05\/ddd1605_insulin-300x225.jpg 300w, https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/05\/ddd1605_insulin.jpg 500w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/a>Intarcia Therapeutics, a Boston-based drug maker worth a whopping $5.5 billion, announced top-line results for its Phase 3 cardiovascular safety study of its type 2 diabetes treatment.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: rgb(0, 0, 0);\">The investigational therapy is named ITCA 650, a GLP-1 receptor agonist administered through a small injectable pump embedded within the skin,\u00a0<a style=\"color: #bf3b41;\" href=\"http:\/\/fortune.com\/2016\/05\/06\/diabetes-intarcia-milestone\/\" target=\"_blank\" rel=\"noopener\"><span style=\"color: rgb(0, 0, 0);\">according to\u00a0<em>Fortune.<\/em><\/span><\/a>\u00a0This process only takes a few minutes and needs to be performed one to two times per year eliminating the need for arduous daily or weekly injections.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: rgb(0, 0, 0);\">Over 4,000 type 2 diabetes patients took part in this placebo-controlled global study over the course of three years. The purpose of this experiment was to assess the potential cardiovascular risk of type 2 diabetes therapies.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: rgb(0, 0, 0);\">The proctors of the study tested 60 micrograms of the drug versus placebo. Average treatment durations lasted 1.2 years with a total of 160 major adverse cardiac events reported.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: rgb(0, 0, 0);\">However, Intarcia\u2019s release\u00a0<a style=\"color: #bf3b41;\" href=\"http:\/\/www.intarcia.com\/media\/press-releases\/2016-may-6-cardiovascular-safety.html\" target=\"_blank\" rel=\"noopener\"><span style=\"color: rgb(0, 0, 0);\">specified<\/span><\/a>\u00a0\u201cthe overall safety and tolerability data for ITCA 650 was consistent with the three Phase 3 trials that have already been presented and what is documented in the published literature,\u201d regarding similar GLP-1 receptor agonists.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: rgb(0, 0, 0);\">Next, Intarcia will aim for an FDA filing at the end of July and raised\u00a0$75 million to fund manufacturing efforts\u00a0if the FDA grants approval. ITCA 650 would be the first GLP-1 therapy capable of delivering a full year of treatment through an osmotic mini-pump if it\u2019s able to reach market.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: rgb(0, 0, 0);\">Plus, Intarcia would be able to capitalize on a lucrative opportunity. A July 2015\u00a0<a style=\"color: #bf3b41;\" href=\"http:\/\/www.dddmag.com\/articles\/2015\/07\/type-2-diabetes-mellitus-treatment-market-value-will-reach-39b-2021\" target=\"_blank\" rel=\"noopener\"><span style=\"color: rgb(0, 0, 0);\">report<\/span><\/a>\u00a0from business intelligence provider GBI Research projects that the market for these therapeutics will reach $39 billion by 2021 due to benefits like easier administration methods and rising prevalence of the disease.\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The proctors of the study tested 60 micrograms of the drug versus placebo. Average treatment durations lasted 1.2 years with a total of 160 major adverse cardiac events reported.<\/p>\n","protected":false},"author":6,"featured_media":8764,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[26,17],"tags":[],"class_list":["post-8763","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicine","category-research"],"featured_image_urls":{"full":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/05\/ddd1605_insulin.jpg",500,375,false],"thumbnail":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/05\/ddd1605_insulin-150x150.jpg",150,150,true],"medium":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/05\/ddd1605_insulin-300x225.jpg",300,225,true],"medium_large":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/05\/ddd1605_insulin.jpg",500,375,false],"large":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/05\/ddd1605_insulin.jpg",500,375,false],"1536x1536":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/05\/ddd1605_insulin.jpg",500,375,false],"2048x2048":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/05\/ddd1605_insulin.jpg",500,375,false],"ultp_layout_landscape_large":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/05\/ddd1605_insulin.jpg",500,375,false],"ultp_layout_landscape":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/05\/ddd1605_insulin.jpg",500,375,false],"ultp_layout_portrait":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/05\/ddd1605_insulin.jpg",500,375,false],"ultp_layout_square":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/05\/ddd1605_insulin.jpg",500,375,false],"newspaper-x-single-post":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/05\/ddd1605_insulin.jpg",500,375,false],"newspaper-x-recent-post-big":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/05\/ddd1605_insulin.jpg",480,360,false],"newspaper-x-recent-post-list-image":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/05\/ddd1605_insulin.jpg",87,65,false],"web-stories-poster-portrait":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/05\/ddd1605_insulin.jpg",500,375,false],"web-stories-publisher-logo":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/05\/ddd1605_insulin.jpg",96,72,false],"web-stories-thumbnail":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/05\/ddd1605_insulin.jpg",150,113,false]},"author_info":{"info":["Amrita Tuladhar"]},"category_info":"<a href=\"https:\/\/www.revoscience.com\/en\/category\/health\/medicine\/\" rel=\"category tag\">Medicine<\/a> <a href=\"https:\/\/www.revoscience.com\/en\/category\/news\/research\/\" rel=\"category tag\">Research<\/a>","tag_info":"Research","comment_count":"0","_links":{"self":[{"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/posts\/8763","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/comments?post=8763"}],"version-history":[{"count":0,"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/posts\/8763\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/media\/8764"}],"wp:attachment":[{"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/media?parent=8763"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/categories?post=8763"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/tags?post=8763"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}