Type 2 diabetes drug Adlyxin approved by FDA
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.
Senior Writer
As a Senior Writer for TriMed Media Group, Katherine primarily focuses on producing news stories, Q&As and features for Cardiovascular Business. She reports on several facets of the cardiology industry, including emerging technology, new clinical trials and findings, and quality initiatives among providers. She is based out of TriMed's Chicago office and holds a bachelor's degree in journalism from Columbia College Chicago. Her work has appeared in Modern Healthcare, Crain's Chicago Business and The Detroit News. She joined TriMed in 2016.