FDA Approves Diabetes Drug
Type 2 diabetes is a chronic health condition that can lead to a wide array of diseases, such as cardiovascular disease, kidney damage and nerve damage when left untreated. Even though there are several diabetes medications out there, researchers continue to develop new and better ones. The latest one, Tanzeum (albigluude), was just approved by the United States Food and Drug Administration (FDA).
The FDA approved Tanzeum after reviewing the findings of eight clinical trials that involved more than 2,000 participants with type 2 diabetes. From these trials, the FDA concluded that Tanzeum could be prescribed as a stand-alone treatment regimen or in combination with other diabetes drugs, which include metformin, glimepiride, pioglitazone or insulin. People taking Tanzeum should maintain a healthy diet and exercise level.
"Tanzeum is a new treatment option for the millions of Americans living with type 2 diabetes," said 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."
Tanzeum will be produced and distributed with a boxed warning informing patients that the drug may increase one's risk of thyroid tumors. However, this risk factor has not been proven by science. The FDA has mandated the company to conduct studies examining the drug's possible effect on the development of such tumors and any potential risks the drug might have on the cardiovascular system. These post-approval studies will also need to examine the effectiveness of the drug for children.
Tanzeum, manufactured by GlaxoSmithKline, is an injectable drug that delivers a hormone known as glucagon-like peptide-1 receptor agonist. The hormone helps the body regulate blood sugar levels. The drug only needs to be injected once per week. The most common side effects include diarrhea, nauseas and injection-site reactions.
The drug was not approved for patients with type 1 diabetes. The FDA's press release can be found here.