FDA Approves Albiglutide for Type 2 Diabetes

By Kristin J. Kelley

The FDA has approved albiglutide (marketed as Tanzeum), a glucagon-like peptide-1 (GLP-1) receptor agonist, for use along with diet and exercise to treat adults with type 2 diabetes.

The weekly injectable will carry a warning about thyroid C-cell tumors seen in rodent studies with other GLP-1-receptor agonists. The drug should not be used in patients with a history of medullary thyroid carcinoma (MTC); the FDA is requiring the manufacturer to conduct a postmarketing study to identify increases in MTC incidence. Additional studies will examine the drug's safety and efficacy in pediatric patients and in those at high cardiovascular risk.

Albiglutide improved glycemic control in some 2000 patients who participated in eight clinical trials. Common side effects included diarrhea, injection site reactions, and nausea.