New Diabetes Drug Approved
FDA clears albiglutide for glycemic control in adult type 2 diabetes patients.
The FDA has approved albiglutide (Tanzeum) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
The drug, which is a glucagon-like peptide-1 (GLP-1), was studied in 8 clinical trials that involved more than 2,000 type 2 diabetes patients. In all trials, patients demonstrated an improvement in glycated hemoglobin (HbA1c) levels.
“It can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes,” said Curtis Rosebraugh, MD, MPH, director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research. Albiglutide has been studied in combination with other therapies such as insulin and metformin.
The FDA is requiring post-marketing studies to evaluate efficacy in pediatric patients as well as its association with cardiovascular outcomes and medullary thyroid carcinoma.
Albiglutide is manufactured by GlaxoSmithKline based in Wilmington, Del.