Adlyxin gains FDA approval for treating type 2 diabetes
The new treatment is a once-daily injection that improves blood sugar levels, or glycemic control.
“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.”
There are over 29 million people in the U.S. who have type 2 diabetes. More than 90 percent of diabetes cases feature type 2 diabetes. This health condition causes serious harm to the body, including blindness, heart disease, kidney damage and nerve damage.
Adlyxin, a glucagon-like peptide-1 (GLP-1) receptor agonist, is a hormone that can be used to normalize a person’s blood sugar levels. Ten different clinical trials showed the efficacy and safety of the drug; the trials included 5,400 patients living with type 2 diabetes.
In the trials, the treatment was used alone and also with other diabetic medications: pioglitazone, metformin, basal insulin and sulfonylureas. The FDA approval specifically applies to using Adlyxin with diet and exercise to manage the patients' blood sugar levels.
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