April 15, 2014
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FDA approves Tanzeum to improve glycemic control in type 2 diabetes

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The FDA today announced that it has approved albiglutide subcutaneous injection to improve glycemic control in adult patients with type 2 diabetes.

Albiglutide (Tanzeum, GlaxoSmithKline), a glucagon-like peptide-1 receptor agonist, showed HbA1c improvement for more than 2,000 patients in a series of eight clinical trials.

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

The FDA also will require a medullary thyroid carcinoma case registry of at least 15 years to identify any increase in medullary thyroid carcinoma incidence related to use of the drug. The FDA noted in a press conference that a black box warning for thyroid c-cell tumors is consistent across the entire class of GLP-1 receptor agonists. Notably, trials for albiglutide did not show significant changes in calcitonin, a marker for medullary thyroid cancer.

The FDA also recommended further study of albiglutide’s safety and efficacy in pediatric patients with type 2 diabetes.

Additionally, GlaxoSmithKline was requested to pursue a cardiovascular outcomes trial to evaluate the CV risk of albiglutide in patients with high baseline risk for CVD.