FDA approves Farxiga for type 2 diabetes
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The FDA has approved dapagliflozin (Farxiga; Bristol-Myers Squibb and AstraZeneca) tablets to improve glycemic control, with diet and exercise, in adult patients with type 2 diabetes.
“Controlling blood sugar levels is very important in the overall treatment and care of diabetes, and Farxiga provides an additional treatment option for millions of Americans with type 2 diabetes,” said Curtis Rosebraugh, MD, MPH, director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research.
Dapagliflozin is a selective and reversible inhibitor of sodium-glucose co-transporter 2 (SGLT2), which works independently of insulin.
Safety and efficacy 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 dapagliflozin.
Dapagliflozin 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 dapagliflozin:
- A cardiovascular outcomes trial (CVOT) to evaluate the cardiovascular risk of dapagliflozin 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 dapagliflozin-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
In clinical trials the most common side effects observed in patients treated with were genital mycotic infections and urinary tract infections.