Adlyxin has been granted FDA approval as a treatment for type 2 diabetes patients. | Courtesy of Shutterstock
+ Regulatory
Amanda Rupp | Aug 6, 2016

Adlyxin receives FDA approval as type 2 diabetes treatment

Officials with the U.S. Food and Drug Administration recently granted approval of Adlyxin (lixisenatide), which is designed to be used with diet and exercise to improve glycemic control, or blood sugar levels, in type 2 diabetes patients.

This once-daily injection will help over 29 million people who are living with type 2 diabetes. The illness comprises over 90 percent of diabetes cases that are detected within the U.S.

Type 2 diabetes is a serious health concern because high blood sugar levels can raise the chance of major health complications, such as blindness, heart disease, kidney damage and nerve damage.

Adlyxin, a glucagon-like peptide-1 (GLP-1) receptor agonist, is a hormone that balances blood sugar levels. Exactly 10 clinical trials have studied the efficacy and safety of the drug, proving it is useful for patients. There were 5,400 patients enrolled in the studies, which used the drug alone and as a combination with other treatments.

“The FDA continues to support the development of new drug therapies for diabetes management,” Dr. Mary Parks, deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said. “Adlyxin will add to the available treatment options to control blood sugar levels for those with type 2.”

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