the treatment's safety and effectiveness were evaluated in 10 clinical trials that enrolled 5,400 patients
The Food and Drug Administration (FDA) has issued an approval for Adlyxin, a new treatment option for adults with type 2 diabetes.
Adlyxin is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that is taken once a day and helps normalize glycemic control (blood sugar levels). 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.
"The FDA continues to support the development of new drug therapies for diabetes management," said Mary Thanh Hai Parks in a written statement. Parks is the 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."
The drug's safety and effectiveness were evaluated in 10 clinical trials that enrolled 5,400 patients with type 2 diabetes. In these trials, Adlyxin was evaluated both as a standalone therapy and in combination with other FDA-approved diabetic medications, including metformin, sulfonylureas, pioglitazone and basal insulin. Use of Adlyxin improved blood sugar levels in each trial.
The most common side effects associated with Adlyxin are nausea, vomiting, headache, diarrhea and dizziness.
As a condition of the approval, the FDA is requiring the completion of two post-marketing studies: a clinical study to evaluate dosing, efficacy and safety in pediatric patients and a study evaluating the immunogenicity of lixisenatide.
Adlyxin is manufactured by Sanofi-Aventis U.S.