In an effort widen the therapy options for the treatment of the condition, on July 28, 2016, the American Food & Drug Administration (FDA) approved Lixisenatide (Adlyxin), a once-daily injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.
Lixisenatide (Adlyxin) is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety and effectiveness were evaluated in 10 clinical trials that enrolled 5,400 patients with type 2 diabetes. In these trials, Lixisenatide (Adlyxin) was evaluated both as a standalone therapy and in combination with other FDA-approved diabetic medications, including metformin, sulfonylureas, pioglitazone and basal insulin. Use of Lixisenatide (Adlyxin) improved hemoglobin A1c levels (a measure of blood sugar levels) in these trials. Moreover, more than 6,000 patients with type 2 diabetes at risk for atherosclerotic cardiovascular disease were treated with either Lixisenatide (Adlyxin) or a placebo in a cardiovascular outcomes trial. Use of Lixisenatide (Adlyxin) did not increase the risk of cardiovascular adverse events in these patients.
The most common side effects associated with Lixisenatide (Adlyxin) are nausea, vomiting, headache, diarrhea and dizziness. Hypoglycemia in patients treated with both Lixisenatide (Adlyxin) and other antidiabetic drugs such as sulfonylurea and/or basal insulin is another common side effect. In addition, severe hypersensitivity reactions, including anaphylaxis, were reported in clinical trials of Lixisenatide (Adlyxin). Also, Lixisenatide (Adlyxin) should not be used to treat people with type 1 diabetes or patients with increased ketones in their blood or urine (diabetic ketoacidosis).
The FDA is still requiring two types of post-marketing studies for Lixisenatide (Adlyxin), namely a) clinical studies to evaluate dosing, efficacy and safety in paediatric patients, and b) a study evaluating the immunogenicity of Lixisenatide (Adlyxin).