The Food and Drug Administration has approved the once-daily injectable lixisenatide, a glucagonlike peptide-1 (GLP-1) receptor agonist, as an adjunct to diet and exercise for improved glycemic control in adults with type 2 diabetes.
The safety and effectiveness of lixisenatide (Adlyxin, Sanofi) were evaluated either as a standalone therapy or in combination with other FDA-approved treatments in a series of clinical trials that enrolled 5,400 adults with poorly controlled type 2 diabetes. The combinations tested in the GetGoal Duo2 studies included lixisenatide with metformin, sulfonylureas, pioglitazone, or basal insulin. Lixisenatide successfully met the primary endpoint of improved hemoglobin A1c levels.
Sanofi, the drug’s manufacturer, withdrew its original 2013 application for lixisenatide’s approval pending evaluation of its cardiovascular safety profile using data from the randomized, controlled Evaluation of Lixisenatide in Acute Coronary Syndrome ELIXA trial. In that study of more than 6,000 adults with type 2 diabetes at risk for atherosclerotic cardiovascular disease, lixisenatide did not increase the risk of cardiovascular adverse events, which occurred in 13.2% of placebo patients and 13.4% of treatment group patients (N Engl J Med. 2015;373:2247-57).
The drug’s most common side effects are nausea, vomiting, headache, diarrhea, dizziness, and hypoglycemia. Severe hypersensitivity reactions, including anaphylaxis, also were reported in the clinical trials.
Lixisenatide should not be used to treat people with type 1 diabetes or patients with diabetic ketoacidosis.
The drug will be marketed in disposable, 20-mcg single-dose pens to be injected postprandially, once daily, following initial treatment with a once-daily dose of 10 mcg for 14 days.
Lixisenatide is approved in more than 60 countries and marketed as Lyxumia in over 40, according to information on the manufacturer’s website.
Postmarketing studies for lixisenatide will be required to evaluate dosing, efficacy, and safety in pediatric patients, and to evaluate the drug’s immunogenicity, according to an FDA statement.
“The FDA continues to support the development of new drug therapies for diabetes management,” said Mary Thanh Hai Parks, MD, deputy director, Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Adlyxin will add to the available treatment options to control blood sugar levels for those with type 2.”
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