FDA to Review Single Daily Injection Combo Drug for T2DM
Sanofi announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for its investigational fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide as a single daily injection for the treatment of adults with type 2 diabetes.
The NDA submission is based on data from two Phase 3 studies, LixiLan-O and LixiLan-L, which evaluated the safety and efficacy of the fixed-ratio combination in 1,900 patients with uncontrolled diabetes after oral antidiabetic agents (OADs) and after basal insulin therapy, respectively. Both studies reported positive top-line results earlier in 2015.
Sanofi redeemed a priority review voucher (PRV) with the submission, requesting for an expedited 6-month review instead of the standard 10 months.
The fixed-ratio combination consists of insulin glargine, a long-acting insulin, and lixisenatide, a once-daily prandial glucagon-like peptide-1 receptor agonist (GLP-1 RA).For more information call (800) 446-6267 or visit Sanofi.us.