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FDA approves Tanzeum to treat type 2 diabetes
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The U.S. Food and Drug Administration has approved GlaxoSmithKline LLC's Tanzeum (albiglutide) subcutaneous injection to improve glycemic control in adults with type 2 diabetes.
Tanzeum 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 HbA1c level (hemoglobin A1c or glycosylated hemoglobin, a measure of blood sugar control).
Tanzeum has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies, including metformin, glimepiride, pioglitazone, and insulin. Tanzeum 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, the FDA said in a news release.
Tanzeum has a Boxed Warning to warn 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 a type of thyroid cancer called 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 where patients have tumors in more than one gland in their body and that predisposes them to MTC).
The FDA is requiring the following post-marketing studies for Tanzeum:
- A clinical trial to evaluate dosing, efficacy, and safety in pediatric patients
- A medullary thyroid carcinoma (MTC) case registry of at least 15 years duration to identify any increase in 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.
The FDA approved Tanzeum with a Risk Evaluation and Mitigation Strategy which consists of a communication plan to inform health care providers about the serious risks associated with Tanzeum.