Tanzeum Approved for Type 2 Diabetes
TUESDAY April 15, 2014, 2014 -- Tanzeum (albiglutide) has been approved by the U.S. Food and Drug Administration to help control blood sugar in adults with type 2 diabetes.
Some 24 million people in the United States have type 2 diabetes, which is more than 90 percent of all diabetes cases, the agency said Tuesday in a news release. People with the disease are at increased risk of heart problems, blindness, nerve damage and kidney damage.
Tanzeum is a glucagon-like peptide-1 receptor agonist, a hormone that helps regulate blood sugar. 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 standalone 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, in Wilmington, Del.
The FDA has more about this approval.
Posted: April 2014