Bristol-Myers Squibb Co. (BMY) and AstraZeneca (AZN) said Wednesday that the U.S. Food and Drug Administration has extended the action date for dapagliflozin for the treatment of type 2 diabetes by three months. The new Prescription Drug User Fee Act (PDUFA) goal date is January 28, 2012.
In response to an FDA request for additional data on dapagliflozin, Bristol-Myers Squibb and AstraZeneca are submitting data from recently completed and ongoing Phase 3 clinical trials. This data submission constitutes a major amendment to the original new drug application or NDA for dapagliflozin.
Brian Daniels, senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb, said, " Bristol-Myers Squibb and AstraZeneca are committed to dapagliflozin as a potential new therapeutic option for adults with type 2 diabetes. We will continue to work closely with the FDA to support the continued review of the NDA."
Dapagliflozin, an inhibitor of the SGLT2 target in the kidney, is under joint development by Bristol-Myers Squibb and AstraZeneca. Dapagliflozin, as an adjunct to diet and exercise, is being investigated to evaluate its safety and its effect on blood sugar levels (glycosylated hemoglobin levels, or HbA1c), in adults with type 2 diabetes, for use as a monotherapy and in combination with other anti-diabetic agents.
The Centers for Disease Control and Prevention (CDC) estimate that approximately one in every 11 adults in the United States has diagnosed diabetes. Type 2 diabetes accounts for approximately 90 to 95 percent of all cases of diagnosed diabetes in adults.
Type 2 diabetes is a chronic, progressive disease characterized by insulin resistance and/or dysfunction of beta cells in the pancreas, which decreases insulin sensitivity and secretion, leading to elevated glucose levels. Over time, this sustained hyperglycemia contributes to worsening insulin resistance and further beta cell dysfunction.
To date, treatments for type 2 diabetes have focused primarily on insulin-dependent mechanisms. An approach that acts independently of insulin could provide an additional option for adults with type 2 diabetes.
Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to enable the companies to research, develop and commercialize select investigational drugs for type 2 diabetes.
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