{"id":88,"date":"2011-07-20T14:32:50","date_gmt":"2011-07-20T14:32:50","guid":{"rendered":"https:\/\/blogs.nature.com\/spoonful\/2011\/07\/fda-committee-votes-down-first-of-a-kind-diabetes-drugs.html"},"modified":"2011-07-20T14:32:50","modified_gmt":"2011-07-20T14:32:50","slug":"fda_committee_votes_down_first","status":"publish","type":"post","link":"https:\/\/blogs.nature.com\/spoonful\/2011\/07\/fda_committee_votes_down_first.html","title":{"rendered":"FDA committee votes down first-of-a-kind diabetes drugs"},"content":{"rendered":"

\"diabetes-testing-strips.jpg\"The first of a highly anticipated class of diabetes drugs assessed by the US Food and Drug Administration (FDA<\/span>) got the thumbs-down from the agency\u2019s Endocrinologic and Metabolic Drugs Advisory Committee yesterday. The FDA<\/span> panel rejected<\/a> dapagliflozin, developed by Bristol-Myers Squibb and AstraZeneca, by a 9\u20136 margin.<\/p>\n

Unlike current type 2 diabetes medicines, which modulate insulin activity to affect sugar levels in the bloodstream, dapagliflozin regulates blood sugar independently of insulin by preventing the protein sodium-dependent glucose cotransporter 2 (SGLT2) from reabsorbing glucose into the kidney. Usually, this simple sugar is dumped back into the bloodstream, inducing a symptom known as hyperglycemia. But dapagliflozin and similar drugs<\/a> in development cause the kidney to excrete the excess glucose into the urine.<\/p>\n

These SGLT2 inhibitors excite researchers and doctors because they provide \u201ca new option for patients with diabetes with a totally different mechanism of action,\u201d says Steven Shoelson<\/a>, head of pathophysiology and molecular pharmacology at the Joslin Diabetes Center in Boston who is not involved in the development of these drugs.<\/p>\n

In phase 3 trials<\/a>, dapagliflozin proved to regulate blood sugar and even caused weight loss in many of study subjects. However, the FDA<\/span> panel voted down the drug because of safety issues. Notably, patients taking dapagliflozin had higher rates of breast and bladder cancer<\/a> compared to those in the control arms of the trials.<\/p>\n

Looking ahead, other drugmakers developing experimental SGLT2 inhibitors will have to \u201cbe very careful to make sure that they do sufficient numbers of people to test [cancer incidence] adequately,\u201d says Shoelson. Johnson & Johnson have a drug called canagliflozin in phase 3 trials, and Boehringer Ingelheim and Lexicon Pharmaceuticals have a related agent in phase 2 testing.<\/p>\n

The FDA<\/span> doesn\u2019t have to follow the recommendations of its advisory panels, but it usually does. A final decision is due 28 October.<\/p>\n

Image<\/a>: Flickr user bodytel, under Creative Commons<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

The first of a highly anticipated class of diabetes drugs assessed by the US Food and Drug Administration (FDA) got the thumbs-down from the agency\u2019s Endocrinologic and Metabolic Drugs Advisory Committee yesterday. The FDA panel rejected dapagliflozin, developed by Bristol-Myers Squibb and AstraZeneca, by a 9\u20136 margin.  Read more<\/a> Continue reading →<\/span><\/a><\/p>\n","protected":false},"author":128,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13,7],"tags":[],"class_list":["post-88","post","type-post","status-publish","format-standard","hentry","category-diabetes-and-metabolism","category-drugs-drugs-and-more-drugs"],"_links":{"self":[{"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/posts\/88","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/users\/128"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/comments?post=88"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/posts\/88\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/media?parent=88"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/categories?post=88"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/tags?post=88"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}