FDA Okays Tanzeum to Treat Adults with Type 2 Diabetes

GlaxoSmithKline's Tanzeum received a green signal from the U.S. Food and Drug Administration to treat adults with type 2 diabetes.

Early this week, the federal agency gave a nod to albiglutide that will be marketed as Tanzeum to help control blood sugar in adults with type 2 diabetes.  Tanzeum subcutaneous injection will improve glycemic control, along with diet and exercise in patients with type 2 diabetes.

"Tanzeum is a new treatment option for the millions of Americans living with type 2 diabetes," 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, said in a statement. "It can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes."

The newly approved Tanzeum is a glucagon-like peptide receptor agonist. It is a hormone that helps patients regulates blood sugar levels in their body.  The safety and effectiveness of the drug was evaluated in eight clinical trials that involved over 2,000 patients who reported having type 2 diabetes. 

The researchers seen that the patients treated with Tanzeum displayed an improvement in their HbA1c levels.  HbA1c is a measure of blood sugar control.

 The drug was reviewed as a stand-alone therapy and also in combination with other type 2 diabetes therapies that included metformin, glimpiride, pioglitazone and insulin.

This new drug is not approved for people with type1 diabetes, people with high levels of ketones in their blood or urine and should not be used as first-line therapy for patients who cannot be managed with diet and exercise.

FDA cautions users to look at the Boxed Warning. Tanzeum use in rodents was associated with tumors of thyroid gland with some GLP-1 receptor agonists. It is unclear whether the drug triggers the thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC) in humans.

The drug should not be used on those with a family history of MTC or those with Multiple Neoplasia syndrome type 2.

The federal agency calls for post-marketing studies for Tanzeum. The studies include a clinical trial to evaluate dosing, efficacy and safety in pediatric patients. A MTC case registry of latest 15 years duration to see if any increase in MTC incidence was linked to Tanzeum. The post marketing study should also include a cardiovascular outcome trail (CVOT) to evaluate the cardiovascular risk of Tanzeum in patients with high risk of cardiovascular disease.

The common side effects noticed during clinical trials was diarrhea, nausea and injection site reaction. The drug was approved with a Risk Evaluation and Mitigation Strategy (REMS) that has a communication plan to caution health care professional about the health risks associated with the drug.