Sanofi files for Japanese approval of diabetes drug Lyxumia

French drug major Sanofi (Euronext: SAN), has submitted a marketing authorization application for lixisenatide (the proposed trade name in Europe is Lyxumia) to Japan’s Ministry of Health, Labor and Welfare. Lixisenatide is a once-daily investigational GLP-1 agonist, invented by Denmark’s Zealand Pharma (Nasdaq OMX Copenhagen: ZEAL) and licensed to Sanofi for the treatment of type 2 diabetes.

The Japanese application is supported by data from the extensive global GetGoal Phase III clinical trial program, which has assessed the intended use of lixisenatide in the treatment of adults with type 2 diabetes to achieve glycemic control in patients who are not adequately controlled on oral anti-diabetics and/or basal insulin. The application includes data from the GetGoal-L Asia study which has shown positive results on the efficacy and safety of lixisenatide versus placebo in Asian patients with type 2 diabetes who were insufficiently controlled on basal insulin ± sulfonylurea on top of diet and exercise.

Results from the GetGoal program provide clinical evidence for lixisenatide’s good efficacy and safety profile in the treatment of type 2 diabetes, demonstrating a significant reduction in HbA1c, and as expected from a GLP-1 agonist, a low risk of hypoglycemia and in terms of tolerability, mild and transient nausea and vomiting as the most commonly reported adverse events.