New Diabetes Treatment Gets FDA Approval

GlaxoSmithKline announced that the FDA has approved Tanzeum (albiglutide) subcutaneous injection as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Tanzeum, a glucagon-like peptide-1 (GLP-1) receptor agonist, was studied alone and in combination with other antidiabetic therapies, including metformin, glimepiride, pioglitazone, and insulin. It mimics the activity of GLP-1 to normalize blood sugar levels.

RELATED: Endocrine Disorders Resource Center

The safety and efficacy of Tanzeum was evaluated in 8 clinical trials which enrolled over 2,000 patients with type 2 diabetes. Participants in those studies showed improvements in their glycosylated hemoglobin (HbA1c) levels.

The FDA approved Tanzeum with requirements for a Risk Evaluation and Mitigation Strategy (REMS) program to inform healthcare providers about serious risks associated with the drug, including the possibility of thyroid cancer. The FDA is also requiring post-marketing studies evaluating use in pediatric patients, a medullary thyroid carcinoma (MTC) case registry to evaluate cancer risk, and a cardiovascular outcomes trial to observe for potential cardiovascular risk.

For more information call (888) 825-5249 or visit GSK.com.