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Farxiga (Dapaglifozin) Wins FDA Nod for Treatment of Type 2 Diabetes
Agency requires six post-marketing studies (January 8)
The FDA has approved Farxiga (dapaglifozin, Bristol-Myers Squibb/AstraZeneca) tablets to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
Dapaglifozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that blocks the reabsorption of glucose by the kidney, increases glucose excretion, and lowers blood glucose levels. The drug’s safety and efficacy were evaluated in 16 clinical trials involving more than 9,400 patients with type 2 diabetes. These studies showed improvement in hemoglobin A1c, a measure of blood sugar control.
Dapaglifozin has been studied as a stand-alone therapy and in combination with other type 2 diabetes treatments, including metformin, pioglitazone, glimepiride, sitagliptin, and insulin. The drug should not be used to treat people with type 1 diabetes; those who have diabetic ketoacidosis; those with moderate or severe renal impairment or end- stage renal disease; or those on dialysis.
The FDA is requiring six post-marketing studies of Farxiga (dapagliflozin):
- A cardiovascular outcomes trial (CVOT) to evaluate the cardiovascular risk of dapagliflozin in patients with a high baseline risk of cardiovascular disease
- A double-blind, randomized, controlled assessment of the risk of bladder cancer in patients enrolled in the CVOT
- An animal study evaluating the role of dapagliflozin-induced urinary flow/rate and composition changes on bladder tumor promotion in rodents
- Two clinical trials to assess the pharmacokinetics, efficacy, and safety of dapagliflozin in pediatric patients
- An enhanced pharmacovigilance program to monitor reports of liver abnormalities and pregnancy outcomes
Source: FDA; January 8, 2014.