FDA to Review Single Daily Injection Combo Drug for T2DM

FDA to Review Single Daily Injection Combo Drug for T2DM
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.

RELATED: Basaglar Approved for Type 1 and 2 Diabetes Mellitus

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.
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