FDA Approves Weekly Type 2 Diabetes Medicine

On April 15, the US Food and Drug Administration (FDA) approved the once-weekly injectable Type 2 diabetes medicine albiglutide (brand name Tanzeum), developed by GlaxoSmithKline (GSK). Tanzeum is a new member of the class of drugs known as glucagon-like peptide-1 (GLP-1) receptor agonists. (Exenatide [Byetta and Bydureon] and liraglutide [Victoza] are the other members of this drug class.)

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GLP-1 agonists work by stimulating the insulin-producing beta cells of the pancreas to release insulin in response to high blood glucose levels. Because of their glucose-dependent mechanism of action, drugs of this class are associated with a low rate of hypoglycemia (low blood glucose).

Tanzeum, which is approved for use in conjunction with diet and exercise in adults with Type 2 diabetes, is administered via an injector pen with a 5-millimeter, 29-gauge needle. In a series of clinical trials known as the Harmony program, Tanzeum was associated with reductions in A1C (an indicator of blood glucose control over the previous 2–3 months) of up to 1.0%.

The medicine will be offered in 30-milligram and 50-milligram doses to be taken once weekly, with or without food. Tanzeum is approved for use alone or in combination with metformin (Glucophage and others), glimepiride (Amaryl), pioglitazone (Actos), and insulin (with the exception of mealtime insulin).

The label carries a warning stating that some medicines in the same drug class as Tanzeum have caused certain types of thyroid tumors in studies with rats, but that it is not known whether these drugs cause such tumors in humans. The medicine should not be used in people with a personal or family history of medullary thyroid cancer or in those who have multiple endocrine neoplasia syndrome type 2.

The manufacturer will be conducting post-marketing trials focusing on the safety and effectiveness of Tanzeum in children, as well as on the incidence of thyroid cancer and the heart risk in people using the medicine.

Tanzeum should not be used to treat Type 1 diabetes or diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body), nor should it be used as a first-line therapy in people who cannot control their condition with diet and exercise alone.

The most common side effects in people using this medicine are diarrhea, nausea, and injection site reactions.

GSK anticipates the medicine, which was approved last month in Europe under the brand name Eperzan, will launch in the United States in the third quarter of 2014.

For more information, see the press releases on the FDA and GSK Web sites.

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