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Blood Glucose Control Drug Approved for Type 2 Diabetes

Diabetes Test (NIH)

(National Institutes of Health)

15 April 2014. The U.S. Food and Drug Administration approved the drug albiglutide to help adults with type 2 diabetes control their blood glucose levels. Albiglutide is marketed in the U.S. under the brand name by Tanzeum by the global pharmaceutical company GlaxoSmithKline.

Diabetes is a chronic condition where the pancreas does not create enough insulin to process the sugar glucose to flow into the blood stream and cells for energy in the body. Type 2 diabetes is a disorder where the pancreas produces some, but not enough insulin, or the body cannot process insulin, and accounts for some 90 percent of all diabetes cases. Type 1 diabetes is an autoimmune condition where the body is tricked into producing little or no insulin. According to the International Diabetes Federation, diabetes affects 382 million people worldwide, of which 24.2 million are in the U.S.

Albiglutide is in a class of drugs known as glucagon-like peptide-1 receptor agonists, which are hormones that generate a greater insulin response, and thus help regulate blood glucose levels. The drug is administered once a week with an injector pen device.

FDA’s approval was based on a series of eight clinical trials testing albiglutide alone and in combinations with other drugs. The trials recruited some 5,000 patients, of which 2,000 were given albiglutide. The most common side effects experienced by patients in clinical trials treated with the drug were diarrhea, nausea, and injection site reactions.

The agency is requiring GlaxoSmithKline conduct post-marketing studies to evaluate safety, dosing, and efficacy of albiglutide for pediatric patients, as well as a trial to determine cardiovascular outcomes of the drug for patients with a high baseline risk of cardiovascular disease.

The company is also required to keep a registry for at least 15 years of patients to track any increase in medullary thyroid carcinoma. Thyroid gland tumors were reported in studies with lab animals given some glucagon-like peptide-1 receptor agonists. The drug is required to carry a warning about the risk of thyroid cancer associated with the drug.

GlaxoSmith Kline says it expects to have Tanzeum on the market in the U.S. during the third quarter of 2014. Albiglutide was approved last month in Europe, marketed under the brand name Eperzan.

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