FDA Approves Liraglutide in Patients with Type 2 Diabetes Mellitus Failing First-Line Treatment

Emma Hitt, PhD

January 26, 2010

January 26, 2010 — Liraglutide injection (Victoza, Novo Nordisk) was approved yesterday by the US Food and Drug Administration (FDA) for the treatment of type 2 diabetes in adults.

Liraglutide is the first once-daily human glucagon-like peptide 1 analog indicated for the treatment of type 2 diabetes. The new treatment is indicated in conjunction with diet and exercise to improve blood sugar control in adults with type 2 diabetes in patients failing first-line therapy.

Liraglutide was evaluated in the Liraglutide Effect and Action in Diabetes phase 3 trials, including 5 studies of more than 3900 patients. As a single agent and in combination with other antidiabetes agents, liraglutide significantly reduced hemoglobin A1c levels, with reductions for liraglutide 1.8 mg, in combination or as monotherapy, ranging from 1.0% to 1.5% in patients with baselines ranging from 8.2% to 8.6%. Overall, liraglutide 1.8 mg + metformin reduced A1C levels by 1.0%.

Liraglutide was also associated with weight loss compared with comparator arms. Liraglutide 1.8 mg + metformin reduced weight by 6.2 pounds.

Common adverse reactions noted included headache, nausea, diarrhea, and antiliraglutide antibody formation. Immunogenicity-related events, such as urticaria, were also reported.

The FDA is requiring several postmarketing studies to ascertain additional information on the safety of liraglutide.

"In addition to a cardiovascular safety study to specifically evaluate the cardiovascular safety of [liraglutide] in a higher risk population, the company also is required to conduct a 5-year epidemiological study using a health claims database to evaluate thyroid and other cancer risks as well as risks for seriously low blood glucose levels (hypoglycemia), pancreatitis, and allergic reactions," the FDA states in their alert, sent yesterday.

A 15-year cancer registry that will evaluate the risk for medullary thyroid cancer is also required. According to the FDA, a proposed risk evaluation and mitigation strategy will "ensure that the benefits of the drug outweigh the risk of acute pancreatitis and the potential risk of medullary thyroid cancer."

According to the company, liraglutide has not been studied "sufficiently in patients with a history of pancreatitis." In addition, liraglutide should not be used to treat type 1 diabetes mellitus or diabetic ketoacidosis and has not been studied in combination with insulin.

According to a company press release, the American College of Endocrinology recently updated their treatment algorithms for type 2 diabetes, writing that human glucagon-like peptide 1 agonists such as liraglutide are a viable "treatment option when blood sugar goals are not met or maintained with lifestyle adjustments and metformin."

Liraglutide will be available in the United States within 4 to 6 weeks. Liraglutide has also been approved in Europe and Japan and is under review in China.


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