Apr 16, 2014 05:12 AM EDT
FDA Approves New Drug to Treat Type 2 Diabetes (Photo : Reuters)
The U.S. Food and Administration approved a new drug named Tanzeum to treat adults with type 2 diabetes.
The new treatment aims to improve glycemic control in adults with type 2 diabetes. The FDA also recommends adopting exercise and a healthy diet while resorting to this treatment.
"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 a press statement. "It can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes."
Tanzeum, a glucagon-like peptide-1 receptor agonist, should be administered once-weekly using an injector pen supplied with a 5mm 29-gauge thin-walled needle. Glucagon-like peptide-1 is an important incretin hormone that helps reduce blood glucose levels, but in people with type 2 diabetes, its production is often reduced or absent.
The drug's safety and effectiveness were evaluated in eight clinical trials involving more than 2,000 patients with type 2 diabetes. Patients participating in the trials showed an improvement in their HbA1c level. The administrative body also clarified that the drug should not be used to treat people with type 1 diabetes; those who have increased ketones in their blood or urine (diabetic ketoacidosis); or as first-line therapy for patients who can't be managed with diet and exercise. They also said that Tanzeum should not be used in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2
The drug comes with a Boxed warning that when it was tested in rodents, it formed thyroid C-cell tumors. Researchers haven't determined whether Tanzeum has the same effect on humans. Side effects observed in patients treated with Tanzeum were diarrhea, nausea, and injection site reactions.
According to statistics by CDC, 25.8 million children and adults in the United States have diabetes. Medical costs incurred by the country are approximately $245 billion per year. Current first-line treatment for type 2 diabetes is diet, weight control and physical activity.
Recently, University of East Anglia (UEA) and King's College London researchers found that flavonoids present in food and drinks like chocolate, berries, tea and red wine can help protect you against type 2 diabetes.
Tanzeum is manufactured by GlaxoSmithKline.
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Source : http://www.hngn.com/articles/28958/20140416/fda-approves-new-drug-treat-type-2-diabetes.htm
