Type 2 diabetes drug, Adlyxin, receives FDA approval

Advances in treatments for type 2 diabetes have led to the development of a once-daily injection capable of controlling blood sugar levels that has just been approved by the FDA.

Adlyxin (lixisenatide), when coupled with a healthy diet and exercise, has been proven to stabilize blood sugar levels in adults with type 2 diabetes.

"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."

Tested in 10 clinical trials with a total of 5,400 patients, Adlyxin was tested as a sole treatment and paired with other diabetes medications including metformin, sulfonylureas, pioglitazone and basal insulin.

Results showed that Adlyxin steadied blood sugar levels, but more research is needed before it can enter the market. The FDA is requiring post-market studies to find out more about dosing, safety and effectiveness in children as well as evaluating the immunogenicity of lixisenatide.