Tanzeum granted FDA approval

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced that it has approved Tanzeum (albiglutide) subcutaneous injection, which is used to improve glycemic control in adults with Type 2 diabetes.



Type 2 diabetes affects approximately 24 million people and accounts for more than 90% of diabetes cases diagnosed in the United States.



"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 shouldn't be used to treat people with Type 1 diabetes; those with increased ketones in their blood or urine; or as first-line therapy for patients who can't be managed with diet and exercise.