Diabetes Q&A

FDA Approves New Injection to Control Blood Sugar in Diabetes

The FDA has approved a new diabetes drug—Tanzeum (albiglutide, GlaxoSmith Kline)—to improve glycemic control in adults with type 2 diabetes. The subcutaneous injection is to be taken in conjunction with diet and exercise.

“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 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.”
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Tanzeum is a glucagon-like peptide-1 (GLP-1) receptor agonist, which is a hormone used to normalize blood sugar levels. The drug was tested in 8 clinical trials of more than 2000 patients with type 2 diabetes. Participants reported an improvement in their HbA1c levels.

The most common side effects were diarrhea, nausea, and injection site reactions.

Tanzeum is not approved to treat patients with type 1 diabetes, those with increased ketones in their blood or urine (diabetic ketoacidosis), or as a first-line therapy in patients who cannot be managed with diet and exercise.

The FDA is requiring the following post-marketing studies:

  • A clinical trial to evaluate dosing, efficacy, and safety in pediatric patients.
  • A medullary thyroid carcinoma (MTC) case registry of at least 15 years duration to identify any increase in MTC incidence related to Tanzeum.
  • A cardiovascular outcomes trial (CVOT) to evaluate the cardiovascular risk of Tanzeum in patients with high baseline risk of cardiovascular disease.

Reference:

FDA. FDA approves Tanzeum to treat type 2 diabetes. 2014 Apr 15. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm393289.htm. Accessed April 15, 2014.