FDA approves once-weekly GLP-1 injectable for type 2 diabetes

April 22, 2014

FDA approved albiglutide (Tanzeum, GlaxoSmithKline), a once-weekly subcutaneous injectable for the treatment of adults with type 2 diabetes. It helps to improve glycemic control, along with diet and exercise.

FDA approved albiglutide (Tanzeum, GlaxoSmithKline), a once-weekly subcutaneous injectable for the treatment of adults with type 2 diabetes. It helps to improve glycemic control, along with diet and exercise.

The glucagon-like peptide-1 (GLP-1) receptor agonist can be used as monotherapy or in combination therapy with other type 2 diabetes agents, including metformin, glimepiride, pioglitazone, and insulin.

“Tanzeum is a new treatment option for the millions of Americans living with type 2 diabetes,” said Curtis Rosebraugh, MD, 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.”

Albiglutide should not be used for the treatment of type 1 diabetes; individuals with diabetic ketoacidosis, or as the first treatment option for individuals who can’t manage with diet and exercise alone.

Albiglutide carries a boxed warning, explaining that the drug should not be used in patients with a history or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2. However, it is not known whether albiglutide causes thyroid C-cell tumors, including MTC, in humans, according to FDA.

The drug has been approved with a Risk Evaluation and Mitigation Strategy (REMS), including a plan to communicate its risk to healthcare providers.

FDA has required the manufacturer to conduct post-marketing studies for albiglutide, including a pediatric clinical trial to evaluate dosing, efficacy, and safety of the product; a cardiovascular outcomes trial for patients with high baseline of cardiovascular disease; and a MTC case registry for at least 15 years to monitor patients for MTC incidence.