AstraZeneca, Bristol-Myers Reports Results From Phase III Study Of Dapagliflozin
(RTTNews.com) - AstraZeneca (AZN, AZN.L) and Bristol-Myers Squibb Company (BMY), Tuesday said Dapagliflozin, an inhibitor used along with a controlled combination of Metformin and Sulfonylurea showed significant reduction in glycosylated hemoglobin levels (HbA1c) in patients with Type 2 Diabetes, in its late-stage study. The patients treated with dapagliflozin 10 mg as an add-on therapy to metformin plus sulfonylurea, met key secondary endpoint of less than 7 percent HbA1c levels, significant reductions in fasting plasma glucose and in body weight compared to placebo at 24 weeks.
Dapagliflozin is currently approved for the treatment of type 2 diabetes in the European Union, Australia, Brazil, Mexico and New Zealand. The companies said that a resubmission of the New Drug Application for dapagliflozin was accepted for review by FDA in July 2013 with a new Prescription Drug User Fee Act goal date of January 11, 2014.
Dapagliflozin is a selective and reversible inhibitor of sodium-glucose cotransporter 2 or SGLT2, which works independently of insulin. The SGLT2 which is found in the kidney is responsible for most of the glucose reabsorption. The kidney's power to reabsorb glucose increases 20 percent in type 2 diabetes patients, which worsens the hyperglycemia associated with the disease. Selective inhibition of SGLT2 reduces the reabsorption of excess glucose and enables its removal through the urine.
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