{"id":33610,"date":"2013-07-27T01:43:14","date_gmt":"2013-07-27T05:43:14","guid":{"rendered":"http:\/\/asweetlife.org\/?post_type=news&p=33610"},"modified":"2015-12-28T09:01:19","modified_gmt":"2015-12-28T14:01:19","slug":"astrazeneca-and-bristol-myers-squibb-resubmit-new-type-2-diabetes-treatment-for-fda-approval","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=33610","title":{"rendered":"AstraZeneca and Bristol-Myers Squibb Resubmit New Type 2 Diabetes Treatment for FDA Approval"},"content":{"rendered":"
\"Bristol-Myers<\/a><\/p>\n

AstraZeneca and Bristol-Myers Squibb Company resubmitted a New Drug Application (NDA) to the U.S. FDA for the investigational drug dapagliflozin for the treatment of adults with type 2 diabetes. The FDA assigned a new Prescription Drug User Fee Act (PDUFA) goal date of Jan. 11, 2014.<\/p>\n

Dapagliflozin, an investigational compound, is a selective and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2), which works independently of insulin. SGLT2, a sodium-glucose cotransporter found predominantly in the kidney, is responsible for approximately 90 percent of glucose reabsorption. In patients with type 2 diabetes, the capacity of the kidney to reabsorb glucose is increased by approximately 20 percent, further exacerbating the hyperglycemia associated with the disease. Dapagliflozin selectively inhibits SGLT2 and as a result promotes the loss of glucose in the urine, lowering blood glucose levels.<\/p>\n<\/div>\n

\n
In\u00a0response to the FDA\u2019s January\u00a02012\u00a0complete response letter requesting additional data<\/a> to allow a better assessment of the benefit-risk profile of dapagliflozin, the NDA resubmission includes several new studies and additional long-term data (up to four years\u2019 duration) from previously submitted studies, resulting in an overall increase in patient-years exposure to dapagliflozin of more than 50 percent.\u00a0The dapagliflozin Phase 2\/3 clinical development program included more than 12,000 adult patients with diabetes (more than 8,000 patients received dapagliflozin) in 26 clinical trials.\u00a0<\/div>\n
\u00a0<\/div>\n

Dapagliflozin\u00a0is currently approved for the treatment of type 2 diabetes in the European Union, Australia, Brazil, Mexico and New Zealand.<\/p>\n

In March,\u00a02013, the\u00a0FDA approved Janssen’s SGLT2 inhibitor, Invokana<\/a>,\u00a0for treatment of adult\u00a0type 2 diabetes\u00a0patients.<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

AstraZeneca and Bristol-Myers Squibb Company resubmitted a New Drug Application (NDA) to the U.S. FDA for the investigational drug dapagliflozin for the treatment of adults with type 2 diabetes. 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