Sanofi announced that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide for the treatment of adults with type 2 diabetes.
The NDA submission is supported by data from two Phase 3 studies evaluating the safety and efficacy of the fixed-ratio combination in more than 1,900 patients who are insufficiently controlled after oral antidiabetic agents (OADs) and after basal insulin therapy, respectively. Both studies met their primary endpoints and their final results will be presented at a medical congress in 2016.
The FDA is anticipated to make a decision in August 2016, following Sanofi’s redemption of a Priority Review voucher with the NDA submission.
The investigational 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.