The FDA has approved Tanzeum to treat type 2 diabetes. According to the American Diabetes Association, type 2 diabetes is the most common form of diabetes, accounting for 90-95 percent of diabetes cases.
“Tanzeum is a new treatment option for the millions of Americans living with type 2 diabetes,” posited Curtis Rosebraugh, M.D., M.P.H., 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.”
If you have type 2 diabetes your body does not use insulin properly. The Mayo Clinic explains that your body either resists the effects of insulin or doesn’t generate enough insulin to maintain a normal glucose level.
“Many type 2 diabetes patients struggle to keep their blood sugar within the recommended levels,” said Vlad Hogenhuis, Senior Vice-President and Head, GSK Global Cardiovascular, Metabolic and Neurosciences Franchise, in a statement released by GlaxoSmithKline. “We are pleased that the approval of Tanzeum provides an effective new weekly GLP-1 treatment option for appropriate patients in the US.”
According to the FDA, Tanzeum is a glucagon-like peptide-1 receptor agonist, a hormone that helps regulate blood sugar levels. Tanzeum’s safety and efficacy were determined in eight clinical trials comprising more than 2,000 patients with type 2 diabetes. Participants in the trials demonstrated an enhancement in their HbA1c level, a measure of blood sugar control.
The FDA adds that Tanzeum should not be utilized to treat individuals with type 1 diabetes and those who have elevated ketones in their blood or urine. Tanzeum is designed to enhance glycemic control, along with diet and exercise, in adults with type 2 diabetes.
In clinical trials, typical side effects seen in patients treated with Tanzeum were diarrhea, nausea and injection site reactions.
Tanzeum is manufactured by GlaxoSmithKline.