The FDA has just approved Sanofi’s lixisenatide (Adlyxin), a new glucagon-like peptide-1 (GLP-1) receptor agonist to improve glycemic control, in conjunction with diet and exercise, in adults with type 2 diabetes.
Adlyxin will be available in a disposable prefilled injectable pen in a single dose of 20 μg. Patients will also receive a disposable prefilled pen in a single dose of 10 μg that they should initiate once daily for 14 days. On day 15, patients will increase the dosage to 20 μg once daily, according to the manufacturer.
Mary Thanh Hai Parks, MD, deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, commented that “Adlyxin will add to the available treatment options to control blood sugar levels for those with type 2.”
The GLP-1 receptor agonist’s FDA approval was partially based on results from the GetGoal clinical program, which included 13 clinical trials involving more than 5000 subjects worldwide, evaluated the safety and efficacy of lixisenatide in adults with type 2 diabetes. All studies successfully met the primary efficacy endpoint of hemoglobin A1C reduction.
Sanofi originally submitted a new drug application for lixisenatide in 2013, but the company pulled that application because the FDA was concerned about the cardiovascular safety of similar diabetes drugs. However, the subsequent ELIXA trial successfully addressed the FDA’s request to demonstrate that lixisenatide does not increase the risk of cardiovascular adverse events.
The most common side effects associated with Adlyxin are nausea, vomiting, headache, diarrhea, and dizziness. Hypoglycemia in patients treated with both 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.
The FDA is requiring postmarketing studies on Adlyxin to evaluate dosing, efficacy, and safety in pediatric patients, as well as the drug’s immunogenicity.