FDA Approves GSK's Tanzeum For Type 2 Diabetes
GlaxoSmithKline announced that the U.S. Food and Drug Administration (FDA) has approved Tanzeum (albiglutide) for subcutaneous injection as a once-weekly treatment for Type 2 diabetes. The drug has been approved as an adjunct to proper diet and exercise for improved glycemic control in adult patients with Type 2 diabetes mellitus.
Albiglutide is a glucagon-like peptide-1 receptor agonist (GLP-1) and biological product administered using an injector pen supplied with a 5mm 29-gauge thin-walled needle. Glucagon-like peptide-1 is a crucial incretin hormone often reduced or absent in people with Type 2 diabetes.
“Tanzeum is a new treatment option for the millions of Americans living with type 2 diabetes. 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, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.
Type 2 diabetes affects an estimated 24 million people around the world and accounts for over 90 percent of diagnosed diabetes case in the U.S. Options for treatment include lifestyle changes, such as exercise and proper diet, but patients with advanced stages of the disease may require the addition of medications to control blood sugar levels. Elevated blood sugar levels over time can lead to increased risk for serious complications such as heart disease, blindness, and nerve damage.
Vlad Hogenhuis, SVP and Head of GSK Global Cardiovascular, Metabolic and Neurosciences Franchise, said, “Many type 2 diabetes patients struggle to keep their blood sugar within the recommended levels. We are pleased that the approval of Tanzeum provides an effective new weekly GLP-1 treatment option for appropriate patients in the US.”
The FDA approval is based on the Phase III Harmony program comprising eight trials and involving more than 5,000 patients. Participants in the trial showed an improvement in their hemoglobin A1c or glycosylated hemoglobin (HbA1c) levels, a measure of blood sugar control.