Sanofi has submitted updated information on a pen delivery device as part of its new drug application (NDA) for the investigational once-daily, fixed-ratio combination of basal insulin glargine 100 U/mL and the glucagon-like peptide-1 (GLP-1) receptor agonist lixisenatide for the treatment of adults with type-2 diabetes. The additional information, submitted at the FDA’s request, constitutes a major amendment to the NDA, resulting in an extension of the Prescription Drug User Fee Act (PDUFA) goal date by three months to November 2016.
Sanofi submitted its NDA for the investigational fixed-ratio combination of insulin glargine and lixisenatide in December 2015. The NDA submission was based on data from the phase 3 LixiLan-O and LixiLan-L trials, which both reported positive top-line results earlier in 2015. These studies enrolled more than 1,900 patients worldwide to evaluate the safety and efficacy of the fixed-ratio combination when used in patient populations uncontrolled after oral antidiabetic agents and after basal insulin therapy, respectively.
On May 25, 2016, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 12 to 2 in favor of approval of the NDA for the fixed-ratio combination.