Jardiance Approved for Type 2 Diabetes
FRIDAY, Aug. 1, 2014 -- Jardiance (empagliflozin) has been approved by the U.S. Food and Drug Administration to treat type 2 diabetes, which accounts for some 90 percent of diabetes cases in the United States, the agency said Friday in a news release.
Affecting some 26 million people in the United States, the disease can lead to complications including heart disease, blindness and nerve and kidney damage, the FDA said.
Jardiance, from a class of drugs called "sodium glucose co-transporter 2 inhibitors," is designed to block re-absorption of blood sugar by the kidneys. Its safety and effectiveness were evaluated in clinical studies involving 4,480 people with type 2 diabetes.
The drug should not be used to treat type 1 diabetes, in people with severe kidney impairment, among people with increased ketones in the blood or urine, or in people on dialysis, the FDA said.
The agency said it has ordered several post-marketing studies of the new drug, including an evaluation of its effects on the cardiovascular system.
The most common side effects are urinary tract infection and female genital infection. The drug also may cause dehydration, leading to a significant drop in blood pressure, the FDA said.
Jardiance is distributed by Boehringer Ingelheim Pharmaceuticals, based in Ridgefield, Conn.
Visit the FDA to learn more.
Posted: August 2014