WASHINGTON — A new sodium-glucose co-transporter 2 (SGLT2) inhibitor has been approved to treat type 2 diabetes.
The Food and Drug Administration approved Farxiga (dapaglifozin) tablets to improve glycemic control, along with diet and exercise, in adults. Farxiga is marketed by Bristol-Myers Squibb Company, Princeton, NJ, and AstraZeneca Pharmaceuticals LP, Wilmington, DE.
“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.
SGLT2 inhibitors block the reabsorption of glucose by the kidney, increase glucose excretion and lower blood glucose levels.
Farxiga’s safety and effectiveness were evaluated in 16 clinical trials involving more than 9,400 patients with type 2 diabetes. The drug was shown to improve patients HbA1c measurements.
The studies involved Farxiga both as a monotherapy and in combination with other type 2 diabetes medications, including metformin, pioglitazone, glimepiride, sitagliptin and insulin.
The FDA noted that Farxiga should not be used to treat people with type 1 diabetes, diabetic ketoacidosis or moderate or severe renal impairment, end stage renal disease or who are on dialysis.
Because an increased number of bladder cancers were diagnosed among Farxiga users in clinical trials, the FDA also does not recommend Farxiga is not recommended for patients with active bladder cancer and suggests that patients with a history of bladder cancer talk to their physician before initiation of the therapy.
Farxiga can cause dehydration, leading to hypotension that can result in dizziness and/or fainting and a decline in renal function. The elderly, patients with impaired renal function and patients on diuretics to treat other conditions appeared to be more susceptible to this risk, the FDA said.
Six post-marketing studies are being required for Farxiga.
Genital mycotic (fungal) infections and urinary tract infections are among the drug’s side effects.