Dr. Mary Parks, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, said type 2 diabetes, the most common form of the disease, affects about 24 million people and accounts for more than 90 percent of U.S. diabetes cases.
"Invokana, or canagliflozin, is the first diabetes treatment approved in a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors," Parks said in a statement. "We continue to advance innovation with the approval of new drug classes that provide additional treatment options for chronic conditions that impact public health."
Invokana, manufactured for Janssen Pharmaceuticals, Inc., in Titusville, N.J., blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels in diabetics who have elevated blood glucose levels.
Its safety and effectiveness were evaluated in nine clinical trials involving more than 10,285 patients with type 2 diabetes. The trials showed improvement in hemoglobin A1c levels -- a measure of blood sugar control -- and fasting plasma glucose, blood sugar, levels.
Invokana was studied as a standalone therapy and in combination with other type 2 diabetes therapies including metformin, sulfonylurea, pioglitazone and insulin. The most common side effects of the drug was vaginal yeast infection and urinary tract infection.
Because Invokana is associated with a diuretic effect, it can cause a sudden fall in blood pressure while standing, which may result in dizziness or fainting, the manufacturer said.
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