New GLP-1 receptor agonist approved

Albiglutide (Tanzeum), a glucagon-like peptide-1 (GLP-1) receptor agonist, was recently approved by the FDA to treat type 2 diabetes in adults, along with diet and exercise.

The safety and effectiveness of this subcutaneous injection were evaluated in 8 trials involving more than 2,000 patients, in which patients taking the drug showed improvements in their HbA1c levels. Albiglutide has been studied as a stand-alone therapy and in combination with other drugs, including metformin, glimepiride, pioglitazone, and insulin. It should not be used to treat people with type 1 diabetes or diabetic ketoacidosis, or as a first-line therapy.

Albiglutide carries a boxed warning to warn that thyroid C-cell tumors have been observed in rodent studies with some GLP-1 receptor agonists but that it is unknown whether the drug causes such tumors, including medullary thyroid carcinoma (MTC), in humans. It 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 FDA is requiring postmarketing studies related to pediatric use, risks of MTC, and cardiovascular outcomes.

The most common side effects are diarrhea, nausea, and injection site reactions, according to an FDA press release.

The FDA also recently approved a new indication for the Dexcom G4 Platinum Continuous Monitoring System for patients with diabetes who are 2 to 17 years of age. The system, which monitors blood glucose levels, had already been approved for patients ages 18 and older.