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The FDA has approved albiglutide (Tanzeum), a once-weekly GLP-1 agonist for type 2 diabetes, the agency announced.
The drug is indicated for improving glycemic control along with diet and exercise, and can be used alone or in combination with existing diabetes drugs, .
The drug will, however, carry a risk evaluation and mitigation strategy (REMS) to inform healthcare providers about the "serious risks associated with Tanzeum," according to the release.
It will also have a boxed warning on thyroid C-cell tumors (including medullary thyroid carcinoma) that have been observed in animal studies of some of the GLP-1 agonists, and drugmaker GlaxoSmithKline will have to conduct three postmarketing studies:
- A case registry of at least 15 years' duration to identify any increase in medullary thyroid cancer
- A cardiovascular outcomes trial in patients with high baseline risk of cardiovascular disease, now being required for all type 2 diabetes drugs
- A trial in pediatric patients
Approval follows eight clinical trials in the HARMONY program that enrolled more than 2,000 patients with type 2 diabetes and looked at the drug as both a standalone agent and in combinations including metformin, glimepiride (Amaryl), pioglitazone (Actos), and insulin.
The FDA cautioned that the drug shouldn't be used in type 1 diabetes, in patients with diabetic ketoacidosis, or as a first-line therapy in patients who don't respond to diet and exercise.
It is also contraindicated in patients with a history of medullary thyroid cancer and in those with Multiple Endocrine Neoplasia syndrome type 2.
In the trials, the most common side effects were diarrhea, nausea, and injection site reactions.
Only one other weekly GLP-1 agonist is currently on the market. Bydureon, or extended-release exenatide (Byetta), was approved in January 2012 after years of back-and-forth with the FDA. Initially submitted for approval in 2009, delays ensued after concerns about potential cardiovascular side effects, pancreatitis, and thyroid cancer.