The U.S. Food and Drug Administration has approved Tanzeum, a diabetes drug developed as a once-a-week injection treatment for type 2 diabetes, drug maker GlaxoSmithKline has announced.
Tanzeum (albiglutide) is described by the FDA as a "glucagon-like peptide-1 (GLP-1) receptor agonist -- a hormone that helps normalize patients' blood sugar levels."
"Tanzeum is a new treatment option for the millions of Americans living with type 2 diabetes," says Curtis Rosebraugh, 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."
The effectiveness and safety of the subcutaneously injectable drug has been evaluated in eight separate clinical trials with more than 2,000 type 2 diabetes patients. Side effects seem limited to nausea, diarrhea or reactions experienced at the injection site.
Tanzeum joins a number of other approved injectable diabetes medicines including Victoza, Bydureon and Byetta.
Type 2 diabetes -- a condition characterized by high blood sugar levels, known as hyperglycemia. -- accounts for around 90 percent of U.S. diagnosed diabetes cases, affecting around 25 million patients here and a total of 382 million worldwide.
"Many type 2 diabetes patients struggle to keep their blood sugar within the recommended levels," says Vlad Hogenhuis, head and senior Vice-President of GSK Global Cardiovascular, Metabolic and Neurosciences Franchise. "We are pleased that the approval of Tanzeum provides an effective new weekly GLP-1 treatment option for appropriate patients in the US."
Over time, if not treated, risks of serious Type 2 diabetes complications such as kidney and nerve damage, blindness and heart disease can increase, the FDA says.
The agency has ordered post-marketing studies of the drug, including clinical trials to evaluate dosage, safety and efficiency in pediatric patients and an evaluation of possible cardiovascular risk in patients at a high existing risk of cardiovascular disease.
GlaxoSmithKline says that with the FDA approval, it intends to launch Tanzeum in the United States in the third quarter of 2014.
Tanzeum has not been approved as a treatment of Type 1 diabetes, the FDA noted.
