FDA Approves Tanzeum Injection Drug for Treating Diabetes 2

The drug is a once a week injection and will carry warnings that tumors of the thyroid gland are a possible side effect as they occurred in some rodents during lab testing.  In addition diet and exercise is also recommended along with the drug.  It can be used alone or as a combination and information after the fact is required to be submitted to the FDA.  It was approved in Europe last month as well. 

Glucagon-like peptide-1 is a hormone that helps reduce blood glucose levels that is either non existent or reduced in presence for people affected by diabetes two.  BD

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The U.S. Food and Drug Administration today approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.

Type 2 diabetes affects approximately 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.

"Tanzeum is a new treatment option for the millions of Americans living with type 2 diabetes," said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “It can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes.”

Tanzeum is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety and effectiveness were evaluated in eight clinical trials involving more than 2,000 patients with type 2 diabetes. Patients participating in the trials showed an improvement in their HbA1c level (hemoglobin A1c or glycosylated hemoglobin, a measure of blood sugar control).

Tanzeum has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies, including metformin, glimepiride, pioglitazone, and insulin. Tanzeum should not be used to treat people with type 1 diabetes; those who have increased ketones in their blood or urine (diabetic ketoacidosis); or as first-line therapy for patients who can’t be managed with diet and exercise.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm393289.htm