Lixisenatide Gets FDA Approval To Treat Type 2 Diabetes

Sanofi’s injectable drug lixisenatide (trade name Adlyxin) has been approved by the U.S. Food and Drug Administration for treatment of adults with type 2 diabetes, the company announced.

Lixisenatide is a once-daily glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of adult patients with type 2 diabetes mellitus as an adjunct to diet and exercise.

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. Peter Guenter, Executive Vice President, Head, Global Diabetes & Cardiovascular Business Unit, Sanofi, said:

“The approval of Adlyxin reaffirms our continued commitment to addressing the challenges faced by people living with diabetes when trying to reach and maintain their individual blood glucose (HbA1c) targets. We are pleased with this approval, as it offers us the opportunity to continue helping patients treated with basal insulin who remain uncontrolled.”

Lixisenatide, under the trade name Lyxumia, has been approved in Germany since February 2013 for the treatment of type 2 diabetes mellitus in combination with oral blood-glucose lowering drugs or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control.

A 2015 study showed that lixisenatide, in patients with type 2 diabetes and acute coronary syndrome, did not increase or decrease the rate of cardiovascular (CV) events compared to placebo, according to results of the Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA) trial.

Lixisenatide Approval

The FDA approval of Adlyxin was based on their review of results from the GetGoal clinical program and findings from the ELIXA trial. 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 in adults with type 2 diabetes.

All studies of the GetGoal program successfully met the primary efficacy endpoint of HbA1c reduction. The most common adverse events reported for Adlyxin included nausea, hypoglycemia and vomiting.

Mary Thanh Hai Parks, M.D., deputy director, Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said:

“The FDA continues to support the development of new drug therapies for diabetes management. Adlyxin will add to the available treatment options to control blood sugar levels for those with type 2.”

Type 2 diabetes affects more than 29 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness and nerve and kidney damage.

Lixisenatide belongs to a class of drugs called glucagon-like peptide-1 receptor agonists. One of their advantages over older insulin secretagogues, such as sulfonylureas or meglitinides, is that they have a lower risk of causing hypoglycemia.

Other approved GLP-1 agonists include exenatide (Byetta/Bydureon), approved in 2005/2012, liraglutide (Victoza, Saxenda), approved 2010, albiglutide (Tanzeum), approved in 2014 by GSK and dulaglutide (Trulicity), approved in 2014, manufactured by Eli Lily.