The FDA has approved Adlyxin (lixisenatide, Sanofi), a once-daily mealtime glucagon-like peptide-1 (GLP-1) receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of adults with type-2 diabetes. It is not approved for use in patients with type-1 diabetes or diabetic ketoacidosis.
The approval of lixisenatide was based on FDA review of results from the GetGoal clinical program and findings from the ELIXA trial, which successfully addressed the FDA's request to demonstrate cardiovascular safety. The GetGoal clinical program, which included 13 clinical trials involving more than 5,000 adults with type-2 diabetes worldwide, evaluated the safety and efficacy of lixisenatide. All studies of the GetGoal program successfully met the primary efficacy endpoint of HbA1c reduction. The most common adverse events reported for lixisenatide included nausea, hypoglycemia, and vomiting.
Lixisenatide will be available in a disposable prefilled pen in a single dose of 20 mcg. Patients will also receive a disposable prefilled pen in a single dose of 10 mcg that they should initiate once daily for 14 days. On day 15, patients will increase the dosage to 20 mcg once daily.
Lixisenatide is approved under the proprietary name Lyxumia in more than 60 countries and marketed in more than 40. Commercial launches include most European Union countries, Japan, Brazil, Mexico, and India.
GLP-1 is a peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells. Lixisenatide increases glucose-dependent insulin release, decreased glucagon secretion, and slows gastric emptying.
Source: Sanofi; July 27, 2016.