HealthDay News — The FDA has approved albiglutide (Tanzeum), a once weekly GLP-1 receptor agonist, to help control blood glucose for adults with type 2 diabetes.
The drug is indicated for use in combination with diet and exercise and can be used as a stand-alone therapy or in combination with other diabetes drugs such as metformin, glimepiride (Amaryl), pioglitazone (Actos) or insulin, the agency said.
The injectable drug’s approval is based on safety and effectiveness data from eight clinical trials involving more than 2,000 people that showed albiglutide improved hemoglobin A1c levels. The most common side effects were diarrhea, nausea and injection-site reactions.
Albiglutide’s labeling will include a boxed warning that it may increase the risk of thyroid tumors and a Risk Evaluation and Mitigation Strategy, although a scientific link between the drug and such tumors hasn’t been established, the agency said. Thyroid C-cell tumors have been observed in rodent studies with some GLP-1 receptor agonists, but it is unknown whether albiglutide has the same affect in humans.
The FDA is requiring several post-approval studies to evaluate the drug’s possible link to thyroid tumors; its dosing, effectiveness and safety in children; and cardiovascular outcomes in patients with high baseline risk for cardiovascular disease.
Albiglutide is not indicated to treat people with type 1 diabetes, patients with diabetic ketoacidosis or as a first-line therapy for patients who can’t be managed with diet and exercise, the agency noted. It should also not be used in patients with a history of medullary thyroid carcinoma or those with multiple endocrine neoplasia syndrome type 2.