The Food and Drug Administration on Wednesday approved the U.S. marketing of Farxiga tablets to treat type 2 diabetes, The Los Angeles Times reported.
The tablets, in addition to diet and exercise, will improve glycemic control or blood sugar levels in people with the disease, according to the FDA. The drug blocks the reabsorption of glucose by the kidney, increases glucose excretion and lowers blood glucose levels.
"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," Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research, said in a statement.
The safety and effectiveness of the drug were evaluated in 16 clinical trials involving more than 9,400 people with type 2 diabetes. The most common side effects were fungal and urinary tract infections. More serious reactions included dehydration, a drop in blood pressure and fainting, FDA officials said in a statement.
FDA officials said the drug is not recommended for people with active bladder cancer or a history of the disease because a high number of clinical trial participants who used Farxiga developed bladder cancer.
The agency said it is requiring "six post-marketing studies to further evaluate issues such as risk for cardiovascular disease, bladder cancer risk, use among children and pregnant women, and effects on the liver," HealthDay reported.
Type 2 diabetes, a disorder in which blood glucose, or blood sugar levels are too high, affects about 24 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States.
Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.
The drug is marketed by Bristol-Meyers Squibb Company in New Jersey and AstraZeneca Pharmaceuticals L.P. in Delaware.
