The drug, to be used for blood sugar control along with proper diet and exercise, is designed to prevent re-absorption of glucose by the kidneys. Type 2 diabetes affects some 24 million people, accounting for 90 percent of diabetes cases in the United States, the FDA said.
Farxiga's safety and effectiveness were established in clinical trials involving more than 9,400 people with type 2 diabetes. The most common side effects were fungal infections and urinary tract infections. More serious adverse reactions included dehydration, a drop in blood pressure and fainting.
An abnormally high number of clinical trial participants who used Farxiga developed bladder cancer, so the drug isn't recommended for people with active bladder cancer. People with a history of the disease should consult a physician before using the drug, the FDA said.
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.
The drug is marketed by Princeton, N.J.-based Bristol-Myers Squibb and Wilmington, Del.-based AstraZeneca.
To learn more about this approval, visit the FDA.