FDA to Review Insulin Glargine/Lixisenatide Combination for Type 2 Diabetes
Sanofi has submitted a new drug application to the FDA for combination lixisenatide/insulin glargine.
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 2 phase 3 studies, LixiLan-O and LixiLan-L, which evaluated the safety and efficacy of the fixed-ratio combination in 1900 patients with uncontrolled diabetes after oral antidiabetic agents and after basal insulin therapy, respectively. Both studies reported positive top-line results earlier in 2015.
Sanofi redeemed a priority review voucher 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.
- Sanofi Submits New Drug a for the Once-Daily Fixed-Ratio Combination of Insulin Glargine and Lixisenatide [press release]. Paris, France: Sanofi US; December 23, 2015. http://www.news.sanofi.us/2015-12-23-Sanofi-Submits-New-Drug-Application-for-the-Once-Daily-Fixed-Ratio-Combination-of-Insulin-Glargine-and-Lixisenatide. Accessed December 28, 2015.