FDA Approves Farxiga for Diabetes Type-2

The U.S Food and Drug Administration has approved AstraZeneca drug Farxiga (dapaglifozin) to improve glucose control in people suffering from diabetes. The drug is to be used along with diet and exercise, the agency said Wednesday.

According to Centers of Disease Control and Prevention (CDC) an estimated 25.8 million people in the United States (8.3% of the population) have diabetes. High glucose levels can lead to several health complications such as heart disease, kidney damage, neurological problems and even eye diseases.

Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor and controls diabetes by preventing kidneys from reabsorbing sugars and increasing glucose excretion through urine, Reuters reported.

The drug is marketed by Bristol-Meyers Squibb Company, Princeton, N.J. and AstraZeneca Pharmaceuticals L.P., Wilmington, Del.

"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, M.D., director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research.

The drug's safety and efficacy were evaluated based on data from 16 clinical trials that included over 9,400 patients with type 2 diabetes. Participants in the studies had improved glucose control.

Farxiga shouldn't be used by people who have diabetes type-1, diabetic ketoacidosis or renal impairment, FDA said in a news release. Also, people with a history of bladder problems should avoid taking the drug.

Side-effects of the drug include dehydration, blood pressure, renal problems and dizziness.

The agency has asked the drug-makers to conduct six additional post-marketing trials including a trial for evaluating cardiovascular health risk associated with the drug use.