FDA Approves Lixisenatide for Type 2 Diabetes

By Kristin J. Kelley

Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS

The FDA has approved lixisenatide (Adlyxin) as an adjunct to diet and exercise for treating adults with type 2 diabetes. The once-daily injection — a glucagon-like peptide-1 receptor agonist — helps normalize blood sugar levels. It is not indicated for patients with type 1 diabetes or diabetic ketoacidosis.

Lixisenatide improved hemoglobin A1c levels in some 5400 patients (in 10 trials) who received it either alone or in combination with other drugs (e.g., metformin). Lixisenatide did not affect the rate of cardiovascular events in a cardiovascular outcomes study of some 6000 patients.

Some cases of anaphylaxis were reported in the lixisenatide studies. The most common side effects of the drug include diarrhea, dizziness, headache, nausea, vomiting, and hypoglycemia (when combined with other diabetes drugs). Postmarketing studies will examine lixisenatide's immunogenicity, as well as its safety and efficacy in pediatric patients.