New Type 2 Diabetes Treatment Approved

The FDA has approved Tanzeum subcutaneous injection for those living with type 2 diabetes. FDA is requiring post-marketing studies for Tanzeum, including a clinical trial to evaluate dosing, efficacy, and safety in pediatric patients.

The FDA has approved a new treatment for type 2 diabetes, Tanzeum (albiglutide) subcutaneous injection. The drug, when combined with a healthy diet and regular exercise, improves glycemic control in adults living with type 2 diabetes.

Tanzeum is a "a glucagon-like peptide-1 (GLP-1) receptor agonist" that helps normalize blood sugar levels in those with diabetes. The safety and effectiveness of the drug were evaluated in eight clinical trials that involved more than 2,000 patients with type 2 diabetes. The results of the trials showed an improvement in type 2 diabetics' HbA1c level. The drug has been studied as both a stand-alone therapy and a therapy combined with other treatments.

FDA is requiring post-marketing studies for Tanzeum, including a clinical trial to evaluate dosing, efficacy, and safety in pediatric patients.

"Tanzeum is a new treatment option for the millions of Americans living with type 2 diabetes," said Dr. Curtis Rosebraugh, M.D., MPH, director of the Office of Drug Evaluation II in 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."

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