FDA Accepts Application to Review Dapagliflozin, a Type 2 Treatment


By: Diabetes Health Staff

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.



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