Patients with diabetes now have another option to choose from when looking for a drug to help control and manage insulin levels.
Adlyxin (lixisenatide), a type 2 diabetes medication, was approved by the U.S. Food and Drug Administration July 28.
The medication, manufactured by Sanofi-Aventis U.S., is a once-daily injection that improves glycemic control and blood sugar levels. Its safety and effectiveness were evaluated in 10 clinical trials that had 5,400 patients with type 2 diabetes. Adlyxin was evaluated both as a standalone therapy and in combination with other FDA-approved diabetic medications like metformin, sulfonylureas, pioglitazone and basal insulin. The trials showed that Adlyxin improved hemoglobin A1c levels.
Additionally, in a separate trial, more than 6,000 patients with type 2 diabetes who were at risk for atherosclerotic cardiovascular disease were treated with either Adlyxin or a placebo. The use of Adlyxin did not increase the risk of cardiovascular problems in those patients.
Although the drug was approved, the FDA is requiring Sanofi-Aventis U.S. to complete additional studies to evaluate dosing, efficacy and safety in pediatric patients and the immunogenicity of lixisenatide.