Farxiga (dapaglifozin) tablets to improve glycemic control has approved by the FDA for use in treating Type 2 diabetes after 16 clinical trials involving more than 9,400 patients showed improvement in HbA1c (hemoglogin A1c or glycosylated hemoglobin, a measure of blood sugar, along with diet and exercise, in adults with type 2 diabetes.
Type 2 diabetes affects about 24 million people and accounts for more than 90% of all diabetes cases diagnosed in the US.
“Controlling blood sugar levels is very important in the overall treatment and care of diabetes, and Farxiga acts as glucose co-transporter 2 (SGLT2) inhibitor that blocks the reabsorption of glucose by the kidney, increases glucose excretion, and lowers blood glucose levels,” stated Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.”
Tpsebraugh went on to explain that “Farxiga has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies including metformin, pioglitazone, glimepiride, sitagliptin, and insulin.”
The drug, however, should not be used to treat people with type 1 diabetes; those who have increased ketones in their blood or urine (diabetic ketoacidosis); or those with moderate or severe renal impairment, end stage renal disease, bladder cancer, or patients on dialysis.
In addition, the FDA warned that side effects from usingFarxiga could include dehydration, leading to a drop in blood pressure (hypotension) that can result in dizziness and/or fainting and a decline in renal function, particularly in elderly, patients with impaired renal function, as well as people using diuretics.