FDA Approves Tanzeum (Albiglutide) to Treat Type-2 Diabetes
GLP-1 receptor agonist normalizes blood sugar levels
The FDA has approved Tanzeum (albiglutide, GlaxoSmithKline) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type-2 diabetes.
Type-2 diabetes affects approximately 24 million people and accounts for more than 90% of diabetes cases diagnosed in the U.S. Over time, high blood sugar levels can increase the risk of serious complications, including heart disease, blindness, and nerve and kidney damage.
Albiglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist — a hormone that helps normalize blood sugar levels. 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 hemoglobin A1c level (a measure of blood sugar control).
Albiglutide has been studied as a stand-alone therapy and in combination with other type-2 diabetes therapies, including metformin, glimepiride, pioglitazone, and insulin. Albiglutide should not be used to treat people with type-1 diabetes or those with diabetic ketoacidosis, nor should it be used as first-line therapy for patients who can’t be managed with diet and exercise.
The labeling for Tanzeum (albiglutide) includes a boxed warning, which states that tumors of the thyroid gland (thyroid C-cell tumors) have been observed in rodent studies with some GLP-1 receptor agonists, but that it is unknown whether Tanzeum causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. 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 (a disease in which patients have tumors in more than one gland in their body, which predisposes them to MTC).
The FDA is requiring the following post-marketing studies of Tanzeum:
- A clinical study to evaluate the drug’s dosing, efficacy, and safety in pediatric patients.
- An MTC case registry of at least 15 years’ duration to identify any increase in the MTC incidence related to Tanzeum.
- A cardiovascular outcomes trial to evaluate the cardiovascular risk of Tanzeum in patients with high baseline risk of cardiovascular disease.
In clinical trials, the most common side effects observed in patients treated with Tanzeum were diarrhea, nausea, and injection-site reactions.
The FDA approved Tanzeum with a risk evaluation and mitigation strategy (REMS), which consists of a communication plan to inform health care providers about the serious risks associated with the drug.
Source: FDA; April 15, 2014.