The FDA has approved Farxiga (dapagliflozin; Bristol-Myers Squibb and AstraZeneca) tablets to improve glycemic control, with diet and exercise, in adult patients with type 2 diabetes

Dapagliflozin is a selective and reversible inhibitor of sodium-glucose co-transporter 2 (SGLT2), which works independently of insulin. 

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The safety and efficacy of Farxiga were evaluated in 16 clinical trials that involved more than 9,400 patients with type 2 diabetes. Study results showed improvement in HbA1c after treatment with Farxiga.

Farxiga has been studied as monotherapy and in combination with other type 2 diabetes treatment including, metformin, pioglitazone, glimepiride, sitagliptin, and insulin. 

The FDA has required six post-marketing studies for Farxiga:

  • A cardiovascular outcomes trial (CVOT) to evaluate the cardiovascular risk of Farxiga in patients with high baseline risk of cardiovascular disease
  • A double-blind, randomized, controlled assessment of bladder cancer risk in patients enrolled in the CVOT
  • An animal study evaluating the role of Farxiga-induced urinary flow/rate and composition changes on bladder tumor promotion in rodents
  • Two clinical trials to assess the pharmacokinetics, efficacy, and safety in pediatric patients
  • An enhanced pharmacovigilance program to monitor reports of  liver abnormalities and pregnancy outcomes

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