New daily injection approved for adults with type 2 diabetes
Lixisenatide (Adlyxin), a once-daily injection, was approved by the FDA on July 28 to improve glycemic control in adults with type 2 diabetes.
Lixisenatide (Adlyxin), a once-daily injection, was approved by the FDA on July 28 to improve glycemic control in adults with type 2 diabetes.
In 10 trials of 5,400 patients, the glucagon-like peptide 1 receptor agonist improved HbA1c levels, both as a stand-alone therapy and with other FDA-approved medications for diabetes. In a cardiovascular outcomes trial of more than 6,000 patients with type 2 diabetes at risk for atherosclerotic cardiovascular disease, use of the drug did not increase the risk of cardiovascular adverse events compared to placebo, according to an FDA release.
The drug is not indicated for people with type 1 diabetes or diabetic ketoacidosis. The most common side effects are nausea, vomiting, headache, diarrhea, and dizziness. Another common side effect is hypoglycemia in patients treated with both the drug and other antidiabetic drugs (e.g., sulfonylurea, basal insulin). Severe hypersensitivity reactions, including anaphylaxis, were also reported in clinical trials. Future postmarketing studies will evaluate dosing, efficacy, and safety in pediatric patients, as well as the immunogenicity of lixisenatide.