FDA Approves First-in-Class Drug for Type 2 Diabetes

On March 29, the U.S. Food and Drug Administration (FDA) approved canagliflozin (Invokana), a novel drug used in conjunction with diet and exercise to improve glycemic control in adult patients with type 2 diabetes. Instead of effecting insulin, the drug blocks blood glucose from being reabsorbed by the kidney by expelling it via urine. Part of a class of sodium glucose co-transporter 2 (SGLT2) inhibitors, canagliflozin is the first of its kind on the market.

"We continue to advance innovation with the approval of new drug classes that provide additional treatment options for chronic conditions that impact public health," said Mary Parks, MD, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research.

The drug's approval was based on nine clinical trials with more than 10,000 type 2 diabetes patients. "The trials showed improvement in hemoglobin A1c levels (a measure of blood sugar control) and fasting plasma glucose (blood sugar) levels," the FDA said in a statement. The FDA noted that the most prevalent side effects associated with the drug were vaginal yeast infections and urinary tract infections.

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Although the FDA approved the drug, the agency is requiring the manufacturer, Johnson & Johnson, to conduct five post-marketing studies, including a cardiovascular outcomes trial.

In January, an FDA advisory panel voted 10-5 in favor of approving the drug, but several concerns were raised, including early cardiovascular events and stroke.

According to the FDA, type 2 diabetes affects about 24 million people accounts for approximately 90 percent of diabetes cases in the U.S.


Clinical Topics: Dyslipidemia, Lipid Metabolism

Keywords: Hemoglobin A, Glycosylated, Insulin, Stroke, Urinary Tract Infections, Drug Approval, United States Food and Drug Administration, Sodium, Blood Glucose, Diabetes Mellitus, Type 2, Glucosides, Symporters


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