FDA Approves Tanzeum for Type 2 Diabetes
To be used in conjunction with diet and exercise
TUESDAY, April 15, 2014 (HealthDay News) -- Tanzeum (albiglutide) has been approved by the U.S. Food and Drug Administration to help control blood glucose, along with diet and exercise, in adults with type 2 diabetes.
Tanzeum is a glucagon-like peptide-1 receptor agonist, a hormone that helps regulate blood glucose. The injectable drug's safety and effectiveness -- in combination with diet and exercise -- were evaluated in a clinical trial of more than 2,000 people. The drug can be used as a stand-alone therapy or in combination with other diabetes drugs such as metformin, glimepiride (Amaryl), pioglitazone (Actos) or insulin, the FDA said.
The most common side effects of Tanzeum's use were diarrhea, nausea, and injection-site reactions. The drug's label will include a boxed warning that it may increase the risk of thyroid tumors, although a scientific link between the drug and such tumors hasn't been established, the agency said.
The FDA is requiring several post-approval studies to evaluate the drug's possible link to thyroid tumors, its effectiveness among children, and any risks to the cardiovascular system. It is not to be used by people with type 1 diabetes, the agency added.
Tanzeum is produced by GlaxoSmithKline, based in Wilmington, Del.