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FDA Accepts Application to Review Dapagliflozin, a Type 2 Treatment
AstraZeneca, Bristol-Myers Squibb
The U.S. Food and Drug Administration has accepted an application to review dapagliflozin, a drug for the treatment of type 2 diabetes that is being developed by Bristol-Myers Squibb and AstraZeneca.
Dapagliflozin differs from conventional type 2 drug treatments that target insulin production or use. Instead, dapagliflozin targets sodium-glucose cotransporter-2 (SGLT2), which is located in the kidney. By doing so, the drug encourages the excretion of excess glucose and calories. (Its mechanism of action is described in the recent Diabetes Health article, "Flushing Away High Blood Sugar.")
FDA approval could come by late October this year. The manufacturers have also applied for European approval with the European Medicines Agency.
Before applying to U.S. and European regulators, Bristol-Meyers and AstraZeneca studied dapagliflozin's effects on 6,000 subjects enrolled in 40 clinical studies. For the U.S. market, they also tracked any correlation between the use of the drug and potential cardiovascular problems.
Categories: Blood Sugar, Diabetes, Diabetes, Food, Health Care, Heart Care & Heart Disease, High Blood Sugar, Insulin, Insulin Resistance, Research, Type 2 Issues
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Mar 22, 2011
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Diabetes Health
Diabetes Health is the essential resource for people living with diabetes- both newly diagnosed and experienced as well as the professionals who care for them. We provide balanced expert news and information on living healthfully with diabetes. Each issue includes cutting-edge editorial coverage of new products, research, treatment options, and meaningful lifestyle issues.
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Topics
- Diabetic / Diabetes Health
- Type 1 / 1.5 Diabetes
- Type 2 Diabetes
- Blood Glucose / Sugar
- High/Low Blood Sugar / Fast Acting Glucose
- Insulin- Pumps, Pens & Syringes
- Continuous Glucose Monitors, CGM, Infusion Sets
- Type 2 Medications
- Hyperglycemia
- Hypoglycemia
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